Thibiant International, Inc. – FDA Warning Letter, Mar 15, 2018

The FDA issued a Warning Letter to Thibiant International, Inc. following an inspection from March 6-15, 2018, identifying significant CGMP violations for finished pharmaceuticals, rendering their drug products adulterated.

Key violations include: 1. **Inadequate Investigation of Discrepancies (21 CFR 211.192):** The firm failed to thoroughly investigate drug product failures. Specifically, batch (b)(4) of an OTC drug product repeatedly failed stability tests for pH, viscosity, and specific gravity. Despite knowing the formulation was unstable, a second batch ((b)(4)) was manufactured using the same flawed formulation, released with failing test results, and subsequently failed stability. The firm's OOS procedure allowing release of nonconforming product was deemed unacceptable. 2. **Inadequate Stability Testing Program (21 CFR 211.166(a)):** The firm lacked sufficient stability data to support the two-year expiry of their OTC drug product. Batches (b)(4) and (b)(4) failed long-term stability tests, and the firm's own investigations concluded the formulation was unstable. 3. **Failure to Test Incoming Components (21 CFR 211.84(d)(2)):** The firm failed to test incoming components, including active ingredients like zinc oxide, relying instead on unqualified supplier Certificates of Analysis (COAs). 4