FDA WARNING_LETTER - Orion Vision Group - February 09, 2011

On June 6, 2011, the FDA issued a Warning Letter to Orion Vision Group (Marietta Vision) following an inspection from January 25 to February 9, 2011. The inspection revealed that the firm, a manufacturer of tinted and prosthetic contact lenses and an initial importer of contact lens solution, was not in conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820), rendering their devices adulterated.

Key violations included: 1. **Failure to promptly review, evaluate, and investigate complaints representing MDR reportable events (21 CFR 820.198(d))**: A complaint regarding a chemical burn and keratitis from contact lens solution was not documented as investigated or evaluated for MDR reportability. The firm's response was inadequate, lacking documentation of investigation or product testing results, and failing to confirm MDR filing. Complaint handling procedures also excluded product returns from evaluation. 2. **Failure to have supplier agreements for change notification (21 CFR 820.50(b))**: The firm lacked an agreement with the manufacturer of AquaRefresh contact lens solution to notify them of product changes, and the product label incorrectly stated the manufacturing location. 3. **Failure to document acceptance or rejection of incoming product (21 CFR 820.80(b))**: No incoming inspection documents existed