FDA 483 - CooperVision Inc. - October 24, 2011

The FDA Form 483 details significant deficiencies in the validation and quality system of a facility operating (b)(4) packaging lines with (b)(4) and (b)(4) machines.

**Validation Issues:** * **Performance Qualification (PQ):** The firm failed to adequately validate packaging lines. During PQ, cartons were not opened to verify blister label accuracy against carton labels. The PQ procedure lacked defined numbers of runs, units per run, statistical analysis methods, and data points. Only (b)(4) runs with (b)(4) units were tested, despite typical monthly volumes of (b)(4) cartons and lot sizes of (b)(4) units. Error types, though defined, were not documented during PQ. * **Installation Qualification (IQ) & Operational Qualification (OQ):** IQ results were inadequately documented, with only overall pass/fail stated for sections, not individual tests. The firm uses the owner's manual for preventative maintenance, which specifies (b)(4) cleaning of sensors, but in practice, cleaning occurs every (b)(4) weeks. No OQ testing was performed to assess sensor function under this reduced maintenance schedule.

**Quality System Deficiencies:** * **Finished Device Acceptance:** No procedures are established for finished device acceptance for labeling operations across any products. * **Device History Records (DHR):** No procedure is established for DHRs. * **Correct