FDA WARNING_LETTER - Oculo Plastik, Inc. - September 11, 2015

On December 22, 2015, the FDA issued a Warning Letter to Oculo-Plastik, Inc. following an inspection from September 8-11, 2015, in Montreal, Canada. The inspection revealed that the firm's ocular prostheses, implants, shields, and accessories are adulterated under section 501(h) of the Act, as their manufacturing, packing, storage, or installation methods do not conform to the Quality System (QS) regulation (21 CFR Part 820).

The FDA found four primary violations: 1. **Failure to establish and maintain CAPA procedures (21 CFR 820.100(a)):** CAPA reports lacked evidence of verification/validation, information dissemination to responsible personnel, and proper recording using the required form. The firm's response was inadequate, lacking documentation of revisions and a retrospective review of past CAPAs. 2. **Failure to validate processes (21 CFR 820.75(a)):** The firm did not identify equipment operating parameters for a critical process, which the FDA considers a process requiring validation, despite the firm's assertion that it is fully verifiable. The response was inadequate, lacking documentation of parameter establishment and a clear method for determining when validation is needed. 3. **Failure to maintain equipment calibration procedures (21 CFR 820.72(