FDA WARNING_LETTER - Ophthalmic Technologies, Inc. - August 02, 2007

An FDA inspection of Ophthalmic Technologies, Inc. (OTI) in Toronto, Canada, from July 30 to August 2, 2007, found that the firm's OTI Scan 1000, OTI Scan 2000, and OTI OCT/SLO imaging systems are adulterated. This is due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820) and a failure to establish Medical Device Reporting (MDR) procedures (21 CFR 803.17).

Key QS violations include failures in establishing and maintaining adequate procedures for corrective and preventative actions (CAPA), complaint handling, incoming product acceptance, quality audits, management review, and personnel training (21 CFR 820.100, 820.198, 820.80(b), 820.22, 820.20(c), 820.25(b)). Additionally, OTI failed to develop and implement written MDR procedures for timely event identification, evaluation, and transmission (21 CFR 803.17(a)(1)).

The firm's August 28, 2007, response was deemed inadequate. Consequently, OTI's devices are subject to refusal of admission under an Import Alert. Federal agencies will be informed, impacting contract awards. Premarket approvals for Class III devices and Certificates to Foreign Governments will be withheld until all violations are corrected. OTI must provide a written response within 15 working days detailing corrective actions and a timeline.