CIBA Vision Puerto Rico, Inc. – FDA Warning Letter, Sep 2, 2010

This FDA Warning Letter, dated December 21, 2010, was issued to CIBA Vision Corporation following an inspection from July 21, 2010, to September 2, 2010, at their Cidra, Puerto Rico facility, which manufactures Class II and Class III soft contact lenses. The inspection found the devices adulterated under 21 U.S.C. § 351(h) due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 C.F.R. Part 820).

Key violations include: 1. **Failure to validate processes (21 C.F.R. § 820.75(a)):** The firm lacked documented evidence for sample sizes used in bioburden and sterility tests, and data supporting the effectiveness of microorganism recovery methods. The FDA requested a summary report and timeline for validation, and an assessment of the impact of any changes on distributed products. 2. **Failure to implement adequate corrective and preventive actions (CAPA) (21 C.F.R. § 820.100(a)(3)):** The firm opened three CAPAs for recurrent labeling inconsistencies in distributed products between March and May 2010, indicating ineffective initial corrective actions. This was a repeat deficiency from a 200