FDA WARNING_LETTER - Kolmar Korea Co. Ltd. - September 28, 2017

The FDA inspected Kolmar Korea Co. Ltd.'s drug manufacturing facility from September 25-28, 2017, identifying significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated.

Violations include: 1. **Failure to thoroughly investigate unexplained discrepancies (21 CFR 211.192):** The firm failed to investigate out-of-specification (OOS) assay results for OTC (b)(4) cream lots (b)(4), (b)(4), and (b)(4), invalidating them without scientific justification before releasing products to the U.S. market. The firm's response was inadequate as it lacked a retrospective evaluation of all invalidated OOS results, root cause determination, and explanation for analyst non-adherence to procedures. 2. **Failure to follow written procedures for the quality control unit (21 CFR 211.22(d)):** Employees discarded documents (batch records, COAs, lab worksheets) without required quality unit approval, violating SOP KO-3 Rev. 9. The firm's response was inadequate as it did not address training program effectiveness or specific measures to ensure procedure adherence.

Required corrective actions include a summary report on the retrospective review of invalidated OOS results for U.S.-distributed products, including actions for non-conforming products (e.g., customer notification, recall). Additionally, the firm