Lifestyle GP Company, LLC – FDA Warning Letter, Feb 1, 2008

On September 4, 2008, the FDA issued a Warning Letter to The Lifestyle GP Company, LLC, following an inspection from January 29 to February 1, 2008. The inspection revealed that the firm's daily wear contact lenses are adulterated under 21 U.S.C. 351(h) because manufacturing, packing, storage, or installation methods do not conform to Quality System (QS) regulation (21 CFR Part 820).

Key violations include: 1. **Management Controls (21 CFR 820.20):** Failure to establish and maintain an effective quality system, including unapproved complaint procedures, unadopted forms, unestablished Medical Device Reporting (MDR) procedures, and lack of complaint trending. Obsolete cleaning procedures and failure to maintain Device History Records (DHRs) were also cited. 2. **Corrective and Preventive Action (21 CFR 820.100(b)):** Failure to establish and implement CAPA procedures. 3. **Complaint Handling (21 CFR 820.198(a)(1)):** Inadequate procedures for receiving, reviewing, and evaluating complaints, referencing un-implemented documents from material manufacturers. 4. **Process Validation (21 CFR 820.75(a)):** Failure to validate the cleaning process to ensure complete