Dermameal Co., Ltd. – FDA Warning Letter, Mar 29, 2019

The FDA issued a Warning Letter to Dermameal Co., Ltd. following an inspection from March 25-29, 2019, identifying significant CGMP violations for finished pharmaceuticals, rendering their drug products adulterated. The firm contract manufactures OTC drug products.

Key violations include: 1. **Inadequate Quality Control Unit (21 CFR 211.22(a) & (d)):** The firm distributed 26 out of 41 drug product lots before completing microbial testing, including products for children. The firm's response, citing client agreement and updated procedures, was deemed inadequate as it failed to demonstrate how future releases without complete testing would be prevented or provide evidence that previous batches met quality attributes. 2. **Insufficient Stability Testing Program (21 CFR 211.166(a)):** The stability program lacked assay testing and an ongoing program, placing only a single batch on stability per drug product. The firm's response to revise procedures and place three lots on stability was inadequate due to lack of detail and timeline. 3. **Failure to Test Components and Validate Supplier Analyses (21 CFR 211.84(d)(1) & (2)):** The firm did not perform identity testing on incoming raw materials and active ingredients, relying on unqualified supplier COAs. Additionally, they failed to test all lots of (b)(4) for (b)(4