Cantor & Nissel Ltd. – FDA Warning Letter, Apr 28, 2011

On September 27, 2011, the FDA issued a Warning Letter to Cantor & Nissel, Ltd. following an inspection from April 26-28, 2011, which found their Daily Wear Soft Contact Lenses to be adulterated and misbranded.

The inspection revealed significant violations of the Quality System (QS) regulation (21 CFR Part 820) and Medical Device Reporting (MDR) requirements (21 CFR Part 803). Key violations include:

1. **Failure to maintain adequate complaint files and procedures (21 CFR 820.198(a))**: The firm lacked written complaint handling procedures, processing complaints on CAPA forms instead. This was not addressed in their May 16, 2011 response as it wasn't on the FDA 483. 2. **Failure to establish and maintain equipment maintenance schedules (21 CFR 820.70(g)(1))**: While personnel stated maintenance was performed, documentation was insufficient. The firm's response was deemed adequate for this point. 3. **Failure to verify/validate corrective and preventive actions (21 CFR 820.100(a)(4))**: The firm's CAPA procedure mentioned follow-up verification but did not address validation of corrective actions. The response was deemed inadequate. 4. **