Edge Biologicals Inc. – FDA Warning Letter, Apr 4, 2023

On June 27, 2023, the FDA issued a Warning Letter to a Memphis, TN firm following an inspection from March 20 to April 4, 2023. The firm manufactures Class I and Class II in vitro diagnostics (IVDs) and was found to be in violation of the Quality System (QS) regulation (21 CFR Part 820), rendering their devices adulterated under section 501(h) of the Act.

Key violations include: 1. **Failure to validate processes** (820.75(a)), specifically cleaning for aseptic areas and sterilization of tubing sets. This is a repeated observation from 2012, 2015, and 2018. 2. **Failure to establish adequate CAPA procedures** (820.100(a)), including insufficient analysis of quality data and inadequate investigation of product sterility failures. This is also a repeated observation from 2012, 2015, and 2018. 3. **Failure to establish supplier requirements** (820.50(a)), a repeat from 2018. 4. **Failure to maintain a device master record (DMR)** (820.181), a repeat from 2018. 5. **Failure to control environmental conditions