FDA WARNING_LETTER - Edge Biologicals, Inc. - September 16, 2011

On September 13-16, 2011, an FDA inspection of Edge Biologicals, Inc. in Memphis, Tennessee, revealed that their Mueller Hinton and Thayer Martin Agar products, classified as devices, were adulterated under 21 USC 351(h) due to non-conformance with Quality System (QS) regulation (21 CFR Part 820). The firm also failed to furnish required information under 21 USC 360i and 21 CFR 803, leading to misbranding under 21 USC 352(t)(2).

Key violations included: 1. **Process Validation (21 CFR 820.75(a)):** Failure to validate the de-ionized water system and aseptic fill process. 2. **Design Change Procedures (21 CFR 820.30(i)):** Absence of procedures for validating/verifying design changes. 3. **CAPA (21 CFR 820.100(a) and (b)):** Inadequate documentation of CAPA activities and results, including investigations, verification/validation of corrective actions, and lack of monthly trend analysis. 4. **Complaint Handling (21 CFR 820.198(a)):** Inadequate complaint files, failure to evaluate complaints for MDR reporting, assess affected lots, and