FDA WARNING_LETTER - Gentell - August 25, 2015

On October 5, 2015, the FDA issued a Warning Letter to Gentell Inc. following an inspection from July 29 to August 25, 2015. The inspection revealed that Gentell Inc., a manufacturer of wound dressings and gauzes, was not in conformance with current Good Manufacturing Practice (cGMP) requirements for medical devices, rendering their devices adulterated under 21 U.S.C. § 351(h).

Key violations included: 1. **Failure to adequately establish and maintain an organizational structure** (21 CFR 820.20), lacking appropriate personnel with authority over quality assessment and a defined quality system. 2. **Failure to establish procedures for corrective and preventive action (CAPA)** (21 CFR 820.100(a)), with no established system to identify, investigate, and correct quality problems. 3. **Failure to establish a formally designated unit and procedures for receiving, reviewing, and evaluating complaints** (21 CFR 820.198(a)). 4. **Failure to validate processes** (21 CFR 820.75(a)), including manufacturing processes for tubes, gamma sterilization for dressings, and package sealing. 5. **Failure to maintain a device master record (DMR)** (21 CFR 820.181) with approved specifications. 6