FDA WARNING_LETTER - Mi Gwang Contact Lens Co., Ltd. - July 05, 2012

On July 2-5, 2012, an FDA inspection of Mi Gwang Contact Lens Co., Ltd. in South Korea found their contact lenses to be adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820). The firm's July 17, 2012, response to the FDA 483 was deemed inadequate for several violations.

Key violations include: 1. Failure to establish and maintain adequate procedures for verifying or validating corrective and preventive actions (CAPA) effectiveness (21 CFR 820.100(a)(4)). The firm's response lacked systemic corrective action and sufficient detail on procedural revisions and implementation. 2. Failure to establish and maintain adequate procedures for design verification, including documentation in the Design History File (DHF) (21 CFR 820.30(f)). The firm's response lacked evidence of implementation and training for new procedures. 3. Failure to establish and maintain adequate procedures for validating device design (21 CFR 820.30(g)). This was not addressed in the firm's response as it was not on the FDA 483. 4. Failure to establish and maintain adequate procedures for design transfer into production specifications (21 CFR