HNC Products Inc. – FDA Warning Letter, Mar 17, 2020

The FDA issued a Warning Letter to HNC Products Inc. following a March 10-17, 2020 inspection, citing significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals (21 CFR parts 210 and 211). This renders their drug products adulterated under the FD&C Act.

Key violations include: 1. **Failure to thoroughly investigate OOS results (21 CFR 211.192):** An OOS assay for a sunscreen product lacked critical details, root cause analysis, and CAPA. Original data was overwritten and unavailable. The firm's response was inadequate, and the ability to delete/overwrite results persists. 2. **Inadequate production and process control procedures (21 CFR 211.100(a)):** The firm failed to perform process validation studies (PPQ) for sunscreen products and lacked an ongoing process monitoring program. The provided new procedure was insufficient, lacking detailed protocols and timelines. 3. **Failure to establish an adequate Quality Control Unit (21 CFR 211.22(a)):** The QU lacked independence and effectiveness, failing to review OOS investigations and equipment qualification. No change management or annual product review program existed. The firm's response regarding resource limitations was deemed inadequate.

Additionally, the firm failed to fulfill drug registration and listing obligations under section 510 of the FD