Candela Admits Altering Devices WITHOUT FDA Approval

FDA Adverse Event Information, Medical Device Approval Process, and FDA Corruption

Candela Admits Altering Devices WITHOUT FDA Approval

PostPosted by cveroleyva » Tue Aug 09, 2011 6:36 pm

This little line can be found on page 30: "We have modified some of our products without FDA clearance. The FDA could retroactively decide the modifications were improper and require us to cease marketing and/or recall the modified products."

http://www.getfilings.com/o0001047469-03-031885.html

Their most recent (2008) full 10K report:

Page 20

http://www.sec.gov/Archives/edgar/data/ ... 2_110q.htm


·We have modified some of our products without FDA clearance. The FDA could retroactively decide the modifications were improper and require us to cease marketing and/or recall the modified products.

· Achieving complete compliance with FDA regulations is difficult, and if we fail to comply, we could be subject to FDA enforcement action.

· We could incur substantial costs as a result of product liability claims, including but not limited to costs as a result of product failures for which we are responsible under warranty obligations and as a result of our customer’s potential unavailability of liability insurance coverage.



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