Chemland Co., Ltd. – FDA Warning Letter, Aug 22, 2019

The FDA issued a Warning Letter to Chemland Co., Ltd. following an August 2019 inspection, citing significant CGMP violations for finished pharmaceuticals, rendering their drug products adulterated. The firm's September 2019 response to the FDA 483 was deemed inadequate.

Key violations include: 1. **Inadequate Quality Control Unit (21 CFR 211.22(a)):** The quality unit lacked authority and responsibility. Issues included disabled audit trails on the ICP-OES instrument, master batch records stored as alterable Excel files, and analysts using and not retaining open Excel files for sample preparation and calculations. 2. **Failure to Establish Written Production and Process Control Procedures (21 CFR 211.100(a)):** The firm failed to validate manufacturing processes for OTC drug products. An unrecorded operation involving mixing different batches occurred. Equipment (b)(4) and ICP-OES lacked qualification. Cleaning procedures and validation for the (b)(4) were inadequate, with the equipment not being disassembled for cleaning. 3. **Inadequate Stability Testing Program (21 CFR 211.166(a)):** The stability program for OTC drug products was insufficient, with only one batch per product, limited accelerated stability data, uncontrolled long-term stability conditions, lack of assay tests for active ingredients, and stability/retain samples not in marketed containers.

The FDA requires