FDA WARNING_LETTER - Coastal Contacts Inc. - July 31, 2013

On July 29-31, 2013, an FDA inspection of Coastal Contacts, Inc. in Vancouver, Canada, revealed that their prescription eyeglasses, classified as a device, were adulterated under 21 U.S.C. § 351(h) due to non-conformity with cGMP requirements of the Quality System (QS) regulation (21 CFR Part 820). The firm's August 21, 2013, response to the FDA 483 was deemed inadequate for several violations.

Key violations included: 1. **Failure to establish and maintain CAPA procedures (21 CFR 820.100(a)):** CAPA forms lacked identification of non-conformity, root cause, investigation, and effectiveness assessment. Undocumented rejections and audit failures were noted. The firm's proposed procedure revision lacked an implementation plan or retroactive review. 2. **Failure to maintain complaint files and procedures (21 CFR 820.198(a)):** The complaint procedure did not include provisions for evaluation by a formally designated unit to determine Medical Device Report (MDR) reportability. The firm's plan to establish a unit and conduct a retrospective review by September 30, 2013, was noted, but adequacy could not be determined. 3. **Failure to ensure purchased products/services