Thai Nakorn Patana Co., Ltd, – FDA Warning Letter, Aug 4, 2023

On February 27, 2024, the FDA issued a Warning Letter to Thai Nakorn Patana Co., Ltd. following an inspection from July 31 to August 4, 2023. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. Failure to perform appropriate laboratory determination of satisfactory conformance to final specifications for each batch of drug product, including identity and strength of active ingredients, prior to release (21 CFR 211.165(a)). Specifically, the firm failed to adequately test OTC drug products like (b)(4) for identity and strength. The firm's response was deemed inadequate for lacking sufficient details on testing procedures or a risk assessment for previously released products. 2. The quality control unit failed to exercise its responsibility to ensure drug products comply with CGMP and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).

The firm has committed to ceasing manufacturing of Neotica Crème drugs for the U.S. market. The FDA requires clarification on future plans for drug manufacturing for the U.S. market. The firm is advised to engage a qualified consultant (21 CFR 211.34