FDA Warning Letters Issued to Device Makers

MAUDE - Manufacturer and User Facility Device Experience. MAUDE data represents reports of adverse events involving medical devices. The data consists of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996. Also, warning letters issued to device makers for FDA violations.

FDA CITES SYNERON FOR ADULTURATION OF EMAX

PostPosted by DCNGA » Fri Jan 20, 2012 6:56 pm

This is from late 2010. One of our members was harmed by an eMax:

http://www.fda.gov/ICECI/EnforcementAct ... 240669.htm

Syneron, Inc 12/23/10

Department of Health and Human Services Public Health Service
Food and Drug Administration
Los Angeles District
Pacific Region
19701 Fairchild
Irvine, CA 92612-2506
Telephone: 949-608-2900
FAX: 949-608-4415




WARNING LETTER

W/L 17-11


CERTIFIED MAIL
RETURN RECEIPT REQUESTED


December 23, 2010

Mr. Louis P. Scafuri, CEO
Syneron Inc.
3 Goodyear, Suite A
Irvine, California 92618

Dear Mr. Scafuri:

During an inspection of your firm located in Irvine, California on August 3, 2010, through August 6, 2010, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the eMax System device. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body.

This inspection revealed that the eMax System device is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g). The device is also misbranded under section 502(o) of the Act, 21 U.S.C. 352(o), because you did not notify the agency of your intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. 360(k). For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. 360(k), is deemed satisfied when a PMA is pending before the agency, 21 CFR 807.81(b). The kind of information you need to submit in order to obtain approval or clearance for your device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html1. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.

Additionally, the device is misbranded under section 502(o) of the Act, 21 U.S.C. 352(o), in that the device was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under 21 U.S.C. 360; was not included in a list required by 21 U.S.C. 360(j); or a notice or other information respecting the device was not provided to the FDA as required by 21 U.S.C. 360(k).

Our inspection also revealed that your eMax System device is misbranded under section 502(a) of the Act, 21 U.S.C. 352(a), in that the labeling for your device, namely the eMax User Manual and eMax product brochure, contain statements which represent or suggest that your device is adequate and effective for skin tightening, which representations or suggestions are false or misleading or otherwise contrary to fact because your device is not adequate or effective for such purposes.

Our inspection also revealed your eMax System device is misbranded under section 502(f)(1), 21 U.S.C. 352(f)(1), in that the labeling for the device fails to bear adequate directions for use for the purposes for which it is intended, because adequate directions cannot be written for skin tightening as stated in the eMax User Manual and product brochure since skin tightening is not an approved indication and there are no such devices cleared for this indication.

Given the serious nature of the violations of the Act, the eMax System device manufactured by your firm is subject to refusal of admission under section 801(a) of the Act, 21 U.S.C. § 381(a), in that it appears to be adulterated. As a result, FDA may take steps to refuse these products, known as "detention without physical examination," until these violations are corrected. In order to remove the devices from detention, you should provide a written response to this Warning Letter as described below and correct the violations described in this letter. We will notify you if your response is adequate, and we may need to re-inspect your facility to verify that the appropriate corrections have been made.

You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, premarket approval applications for Class III devices to which the Quality System regulation deviations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.

Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.

In addition, FDA has noted nonconformances with the following Current Good manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at 21 CFR Part 820. These nonconformities include, but are not limited to, the following:

1. Failure to establish and maintain adequate procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meet acceptance criteria until: (1) the activities required by the Device Master Record (DMR) are completed; (2) the associated data and documentation is reviewed; (3) the release is authorized by the signature of a designated individual(s); and (4) the authorization is dated, as required by 21 CFR 820.80(d). For example, your firm’s Acceptance Test Procedure (ATP) and “Final Test” form used in the inspection of imported devices (e.g. eMax System) to ensure conformance with specifications, do not explain how to perform the testing or describe which tests are required.

We have reviewed your response dated August 18, 2010, and have concluded that the adequacy of your response cannot be determined at this time. Your response stated that you would establish a fully documented procedure for finished goods testing including training, process validation, and an internal audit to verify implementation within 60 days. Your response also stated that ATP forms on file would be reviewed for compliance by technical team leaders. Your firm, however, has not provided evidence of implementation of the corrective actions.

2. Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). For example, Clinical Complaints form QA70001 states that “ALL FIELDS MUST BE COMPLETE BEFORE YOUR REQUEST WILL BE PROCESSED.” A review of complaints (b)(6) found all fields were not filled out. There was no documentation on the form stating a reason why the fields were not completed.

We have reviewed your response dated August 18, 2010, and have concluded that the adequacy of your response cannot be determined at this time. Your response stated that QA7001 form was updated to include a statement saying in the case that the information field in the form is not applicable, to add “NA” in the form. Your response also stated that employees who conduct and/or review clinical investigations would be trained on the revised form no later than September 1, 2010. Your firm also stated your corrective action involved reviewing previous investigations reported on form QA7001 to determine: (1) if they were completed properly and met all the firm’s requirements by September 15, 2010, and (2) to verify that any “missing data” did not affect the investigation results. Your firm, however, has not provided evidence of implementation of the corrective actions.

Please send your reply to the Food and Drug Administration, Attention:

Blake Bevill
Compliance Director
Los Angeles District
19701 Fairchild
Irvine, CA 92612-2506

If you have questions regarding any issues in this letter, please contact Marco Esteves, Compliance Officer at 949-608-4439.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.


Sincerely,


Alonza E. Cruse, Director
Los Angeles District

"It is a good thing to learn caution from the misfortunes of others."

"If you wish to succeed in life, make perseverance your bosom friend, experience your wise counselor, caution your elder brother, and hope your guardian genius."
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FDA Warning Letters Issued to Device Makers

PostPosted by DCNGA » Fri Jan 20, 2012 8:13 pm

Not a cosmetic device, but including anyway:

The Lasik Vision Institute 12/16/11

Department of Health and Human Services Public Health Service
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993

WARNING LETTER


DEC 16 2011


VIA UNITED PARCEL SERVICE


Ben L. Cook
Chief Executive Officer
The Lasik Vision Institute
10667 NE 2nd Street
Bellevue, Washington 98004


Dear Mr. Cook:
During an inspection of your firm located in Bellevue, Washington, on June 16-17 and 24, 2011, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is a medical device user facility and is subject to the statutory reporting requirements of the Medical Device Reporting (MDR) regulation, found at Title 21, Code of Federal Regulations (CFR) Part 803.


The ophthalmic laser used at your facility to perform Laser-Assisted In Situ Keratomileusis (LASIK) procedures is a medical device under Section 201 (h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 321 (h). This product is a device because it is intended for the use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or is intended to affect the structure or function of the body.


Our inspection revealed that your facility's devices are misbranded under section 502(t)(2) of the Act, 21 U.S.C. 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. 360i, and 21 CFR Part 803 - Medical Device Reporting. Significant violations include, but are not limited to, the following:


Failure to develop, maintain, and implement adequate written Medical Device Reporting (MDR) procedures, as required by 21 CFR 803.17. For example:


1. There is no evidence that your facility's "Medical Device Reporting Procedure" was implemented, as it does not have an effective date.


2. The procedure fails to describe a standardized review process for determining when an event meets the criteria for reporting, including who is responsible for making the reportability decision ..


3. The procedure fails to provide instructions for the timely submission of complete medical device reports, including instructions for completing and submitting the FDA Form 3500A to the device manufacturer or FDA as required by 21 CFR Part 803.32; instructions for completing and submitting the FDA Form 3500A to the device manufacturer or FDA as required by 21 CFR Part 803.32; circumstances under which an event must be submitted as a 10-day or 5-day report; and how the facility will submit all information reasonably known to it.


4. The procedure fails to provide instructions for the timely transmission of complete medical device reports, including the address for where to submit MDR reports: FDA, CDRH, Medical Device Reporting, P.O. Box 3002, Rockville, MD 20847-3002.


5. The procedure fails to describe how your facility will address documentation and record-keeping requirements including how information the facility obtains will be documented for record keeping purposes.


Your firm should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts.


Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (including any systemic corrective actions) that your firm has taken. If your firm's planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm's response should be comprehensive and address all violations included in this Warning Letter.


Your firm's response should be sent to: Food and Drug Administration, Center for Devices and Radiological Health, Office of Surveillance and Biometrics, MDR Policy Branch, White Oak Building 66, 10903 New Hampshire Avenue, Room 3208, Silver Spring, MD 20993. Refer to the Unique Identification Number #215574 when replying. If you have any questions about the contents of this letter or wish to discuss MDR reportability criteria or schedule further communications, please contact: MDR Policy Branch at (301) 796-6670 or by email at MDRPolicy@fda.hhs.gov.


If your facility wishes to submit MDR reports via electronic submission, it can follow the directions stated at the following URL: http://www.fda.gov/MedicalDevices/devic ... htm#where1


Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm's facility. It is your firm's responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the lnspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.




Sincerely yours,
/S/

Steven D. Silverman

Director
Office of Compliance
Center for Devices and
Radiological Health

cc:

Vision Care Holdings, LLC (dba: LASIK Vision Institute)
200 Palm Beach Lakes Boulevard
Suite 800
West Palm Beach, Florida 33409
"It is a good thing to learn caution from the misfortunes of others."

"If you wish to succeed in life, make perseverance your bosom friend, experience your wise counselor, caution your elder brother, and hope your guardian genius."
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Re: FDA Warning Letters Issued to Device Makers

PostPosted by DCNGA » Fri Jan 20, 2012 9:03 pm

Public Health Service
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993


WARNING LETTER


April 18, 2011

VIA UNITED PARCEL SERVICE

Brian Smith
Refine USA, LLC
340 3rd Avenue South STE C
Jacksonville Beach, Florida 32250

RE: VeinGogh Ohmic Thermolysis System

Dear Mr. Smith

Refer to GEN0900605 when replying to this letter.

The Food and Drug Administration (FDA) has learned that your firm is marketing the VeinGogh Ohmic Thermolysis System in the United States (U.S.) without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).

The Office of Compliance (OC) in the Center for Devices and Radiological Health (CDRH) reviewed your Internet website http://www.veingogh.com1 for VeinGogh Ohmic Thermolysis System. The product is a device within the meaning of Section 201(h) of the Act.

The website or linked pages to the website make statements like:

“Medspa and aesthetic physician offices use the VeinGogh Ohmic Thermolysis System to provide a superior solution for the treatment of fine telangiectasia, spider veins and small angiomas, especially recalcitrant vessels that have shown a resistance to sclerotherapy, laser or IPL treatment. VeinGogh is the fast, easy way to reliably treat these and other cosmetically unacceptable conditions, often with less discomfort compared to older therapies.”

“Does VeinGogh only work on veins? No! VeinGogh can also be used to eliminate cherry angiomas, small hemangiomas, skin tags, spider nevi, and even redness of rosacea”

Refine USA, LLC, of Jacksonville Beach Florida, has listed VeinGogh as a needle-type epilator in FDA’s Registration and Listing Database under 21 CFR 878.5350. Epilators are class I devices intended to remove unwanted hair and are exempt from premarket notification. However, claims like those made above and elsewhere in your website exceed the limitations of exemptions from section 510(k) of the Act, 21 U.S.C. 360(k), for epilators. These claims are a major change or modification to the intended use of this device and require a premarket notification under 21 CFR 807.81(a)(3)(ii).

The device is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g). The device is also misbranded under section 502(o) of the Act, 21 U.S.C. 352(o), because you did not notify the agency of your intent to introduce the device into commercial distribution, as required by sections 510(k) of the Act, 21 U.S.C. 360(k).

The Office of Compliance requests that Refine USA, LLC immediately cease the dissemination of promotional materials for VeinGogh Ohmic Thermolysis System the same as or similar to those described above. You should take prompt action to correct these violations. Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to seizure, injunction, and/or civil money penalties.

Please submit a written response to this letter within 15 working days from the date you receive this letter, describing your intent to comply with this request, listing all promotional materials for VeinGogh Ohmic Thermolysis System the same as or similar to those described above, and explaining your plan for discontinuing use of such materials. Please direct your response to Jason A. Brookbank, Acting Chief, General Surgery Devices Branch at the Food and Drug Administration, 10903 New Hampshire Ave, WO66-3520, Silver Spring, Maryland 20993-0002. We remind you that only written communications are considered official.

The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your promotional materials for VeinGogh Ohmic Thermolysis System comply with each applicable requirement of the Act and FDA implementing regulations.

Sincerely yours,

/s/

Steven D. Silverman
Director
Office of Compliance
Center for Devices and
Radiological Health
"It is a good thing to learn caution from the misfortunes of others."

"If you wish to succeed in life, make perseverance your bosom friend, experience your wise counselor, caution your elder brother, and hope your guardian genius."
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Re: FDA Warning Letters Issued to Device Makers

PostPosted by DCNGA » Fri Jan 20, 2012 9:53 pm

Candela Corporation 19-Sep-01
DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration

Center for Devices and Radiological Health

2098 Gaither Road

Rockville, MD 20850

SEPTEMBER 19, 2001

WARNING LETTER

VIA FEDERAL EXPRESS

VIA FACSIMILE

Mr. William H. McGrail

Vice-President, Research & Development

Candela Corporation

530 Boston Post Road

Wayland, Massachusetts 01778

Re: Candela Mid IR Diode Laser System

(a.k.a. Smoothbeam), KO02421

Dear Mr. McGrail:

The Office of Compliance (OC), Center for Devices and Radiological Health (CDRH), Food and Drug Administration (FDA) has reviewed additional promotional materials for the Candela Mid IR Diode Laser (a.k.a. Smoothbeam). This product is manufactured by Candela Corporation and is a device within the meaning of section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act).

The Smoothbeam was cleared under section 510(k) of the Act and is intended for use in

dermatology for incision, excision, ablation, and vaporization with hemostasis of soft tissue. Additionally, the Candela Dynamic Cooling device was cleared to cool the skin prior to laser treatment and for reducing pain during laser treatment.

In a previous letter from our office dated June 27, 2001, we advised you that promotional claims appearing on your web site or in other promotional materials, implying that Smoothbeam may be used for cosmetic purposes, for skin renewal and/or rejuvenation, or for stimulating collagen "remodeling or deposition, were not cleared by the agency as part of your 5 10(k) submission. Your response of July 6, 2001 made a commitment to revise your web site and promotional materials by September 6, 2001 to remove such claims.

We have re-reviewed your web sites at the Internet address: http://www.smoothbeam.com1

and http://www.clzr.com2, as well as a recent 2001 advertisement titled, Discover Smoothbeam. And send Your patients back in time, and an April 3, 2001 press release titled, Candela Begins Worldwide Shipment of Smoothbeam: A Revolutionary Diode Laser for Skin Renewal. As of September 17, 2001, these materials continue to make claims for the Smoothbeam stating that the device may be used for cosmetic purposes, for the treatment of skin renewal and/or rejuvenation, and for initiating collagen remodeling and deposition. Representative examples of such statements include, but are not limited to the following:

From the advertisement:

- "Skin renewal was never so easy and affordable"

- "It?s about time someone came up with a way to fight the effects of aging. The Smoothbeam Laser is a whole new way to approach skin renewal"

"Featuring our patented LASR (laser-assisted skin renewal) process ...Smoothbeam targets and heats collagen in the upper dermis while protecting the epidermis, stimulating new collagen formation"
From the web:

- "Because the wavelength of the Smoothbeam is gently absorbed by the upper layer of the dermis, what we ?re seeing over time is gradual improvement in the quality, tone, texture, and feel of the skin" (By David J Goldberg, MD., Skin Laser and Surgery Specialist of New York)

- "Discover Smoothbeam. The new non-invasive way to renew skin"

- "The subsequent healing process leads to new collagen deposition"

-Smoothbeam is an elegant, fairly pain[ess method for improving skin without anybody knowing that anything has been done"

- "The patented LASR process. Advanced technolo~ for collagen remodeling"

From Candela?s quarterly newsletter titled, Wavelength (Spring, 2001), Part No. 0920-20- 0012 Rev.01:

- "New non-ablative skin renewal laser technology demonstrated at meetings in Europe, Asia, & US"

"Candela warmed up the winter of 2001 with announcements and demonstrations of the exciting new Smoothbeam skin renewal laser at physicians and key persons meetings in Paris, Tokyo, and Bangkok in January, and in Washington, D. C. in March" (emphasis added)
"The Smoothbeam takes skin renewal to new levels ... "
From the April 3,2001 press release:

- ?Candela is pleased to report the first shipments of Smoothbeam, its newly introduced diode-based skin renewal laser"

"Clinically we see it (sun-damaged or aging skin) that has lost its tone and texture. The unique 1450 nm wavelength of the Smoothbeam is absorbed by water in the damaged collagen. ... This leads the body to create new collagen that has better direction ? it?s thicker, and it leads to better tone and quality of the skin"
Candela also references the body?s natural healing response and its association with collagen remodeling in pictorial representations at http://www.smoothbeam.com/LASR page.htm.

Continued promotion of the Candela Smoothbeam Laser for claims implying that Smoothbeam may be used for cosmetic purposes, for the treatment of skin renewal and/or rejuvenation, for initiating collagen remodeling and deposition, or for fighting the effects of aging cause the Smoothbeam to be misbranded within the meaning of section 502(0) of the Act, in that a notice or other information respecting the modification in the intended use of the device was not provided to FDA as required by21 CFR 807.81 (a)(3)(ii) and section 5 10(k) of the Act, and the device was not found to be substantially equivalent to a predicate device.

The Smoothbeam is also adulterated within the meaning of section 501 (f)(l )(B) of the Act in that it is a Class III device under section 513(f), and does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a), or an approved application for investigational device exemption (IDE) under section 520(g).

Finally, we note that your web site contains a list of upcoming cosmetic laser workshops

scheduled from now through January, 2002 which purport to provide live patient demonstrations and hands-on laser experience using the Smoothbeam laser. Candela should ensure that your presentations, demonstrations, and any lectures at these workshops are strictly limited to the cleared intended use of your device.

This letter is not intended to be an all-inclusive list of deficiencies associated with your

Smoothbeam device. It is your responsibility to ensure adherence to each requirement of the Act and Federal regulations. The specific violations noted in this letter may represent practices used in other promotion or advertising materials used by your firm. You are responsible for investigating and reviewing these materials to assure compliance with applicable regulations.

You should take prompt action to correct these violations. Failure to promptly correct these deviations may result in regulatory action being initiated by FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil penalties. Please notify this office, in writing, within 15 working days of receipt of this letter, outlining the specific steps you have taken to correct the cited violations. Your response should also include all steps being taken to address misleading information currently in the market place and actions to prevent similar violations in the future. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.

Your response should be sent to Mr. Steven E. Budabin, Consumer Safety Officer, Promotion and Advertising Policy Staff (HFZ-302), Office of Compliance, Center for Devices and Radiological Health, 2098 Gaither Road, Rockville, Maryland 20850.

A copy of this letter is being sent to FDA?s New England District Office. Please send a copy of your response to the District Director, Food and Drug Administration, New England District Office (HFR-NWE200), One Montvale Avenue, 4th Floor, Stoneham, Massachusetts 02180.

Sincerely yours,

Larry D. Spears

Acting Director

Office of Compliance

Center for Devices and Radiological Health
"It is a good thing to learn caution from the misfortunes of others."

"If you wish to succeed in life, make perseverance your bosom friend, experience your wise counselor, caution your elder brother, and hope your guardian genius."
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