FDA WARNING_LETTER - Cooper Vision Caribbean Corp. - January 10, 2014

The FDA issued a Warning Letter to Cooper Companies Inc. on February 27, 2014, following an inspection of Cooper Vision Caribbean Corporation in Juana Diaz, Puerto Rico, from December 10, 2013, to January 10, 2014. The inspection determined that the firm, a manufacturer of Class II and Class III contact lenses (Biomedics, Proclear, Biofinity, Avaira & Single Use Silicon), had adulterated devices under Section 501(h) of the Act, as manufacturing methods, facilities, or controls did not conform to Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

The firm's response dated February 3, 2014, was deemed inadequate, failing to fully outline specific corrective actions. Violations included:

1. **Failure to adequately investigate nonconformities (21 CFR § 820.100(a)(3)):** CAPA investigations were incomplete, lacking evaluation of impact on affected devices, implementation of interim controls, and assessment of commercially distributed products. Examples cited include: * CAPA (b)(4) (initiated 12/02/11) for metallic particles in Avaira Toric lenses: Containment activities were delayed until October 2012, risk assessment until 09