CooperVision, Inc. – FDA Warning Letter, Oct 24, 2011

On October 14-24, 2011, an FDA inspection of CooperVision, Inc. in West Henrietta, NY, identified that their Class II and Class III medical devices (daily and extended wear soft contact lenses) were adulterated under Section 501(h) of the Act. The firm's manufacturing, packing, storage, or installation methods did not conform to Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

Key violations included: 1. **Failure to adequately validate processes (21 CFR § 820.75(a))**: Specifically, the firm's (b)(4) packaging lines' quality checks for label information were not fully verified during Performance Qualification (PQ). The PQ procedure lacked defined runs, units per run, statistical analysis methods, and data points. Errors were not documented, and Installation Qualification (IQ) results were inadequately documented. Preventive maintenance (PM) for sensors was not followed per the owner's manual, with cleaning occurring every 15 weeks instead of daily/weekly, without testing for functionality impact. The firm's response to re-validate by April 1, 2012, and review PM by December 1, 2011, was deemed inadequate as it lacked immediate actions or retrospective review for affected products. 2. **Failure to establish finished