CooperVisision Manufacturing Puerto Rico LLC – FDA 483, Apr 25, 2008

This FDA Form 483 documents observations made during an inspection of a firm on April 25, 2008. The inspection revealed three key observations related to quality system requirements.

Observation 1 notes that process validation activities and results for the sterilization of contact lenses in single blisters were not fully documented. Specifically, deviations from pre-established acceptance criteria during the performance qualification protocol for the (b)(4) Autoclave, conducted in July 2002, were not fully reviewed or documented in the final report. Discrepancies found in raw data, but not in the final report, include replacement of temperature indicators, execution of an additional sterilization cycle, an additional cycle for biological indicator testing, and a temperature failure (120 Deg) in one chamber's temperature indicator during "Run 1 Max," with no biological indicator results for this cycle. The firm promised to correct this.

Observation 2 states that complete complaint files are not maintained. The firm failed to fully document the evaluation of the manufacturing process for locally manufactured product lots during investigations of consumer complaints reporting patient reactions from 2005 to July 2007. These evaluations did not comprehensively assess manufacturing records to determine the impact of reported inspection results or other conditions on the reported defects. The firm reported this as corrected, but it was not verified.

Observation 3 indicates that procedures for implementing corrective and preventive actions (CAPA) were incomplete. Trend Procedure #0