Les Laboratoires Blanchard – FDA Warning Letter, Sep 1, 2011

On December 23, 2011, the FDA issued a Warning Letter to Les Laboratoires Blanchard following an inspection from August 29 to September 1, 2011. The inspection revealed that the firm's contact lenses, classified as devices, were adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820) and misbranded under 21 U.S.C. § 352(t)(2) for failing to furnish required information under 21 CFR Part 803 (Medical Device Reporting - MDR).

Key violations include: 1. **Corrective and Preventive Action (CAPA):** Failure to establish and maintain adequate CAPA procedures, specifically regarding effectiveness evaluation and validation of implemented actions (21 CFR 820.100(a)). 2. **Process Control:** Inadequate documentation of monitoring and control methods for the autoclave sterilization process, including identification of equipment used (21 CFR 820.75(b)(2)). 3. **Process Validation:** Failure to review and evaluate process changes or deviations and perform revalidation when appropriate, particularly after equipment replacements (21 CFR 820.75(c)). 4. **Complaint Handling:** Inadequate procedures for receiving,