TAKA USA, INC. – FDA Warning Letter, Jun 6, 2019

On July 29, 2020, the FDA issued a Warning Letter to TAKA USA, Inc. dba Cosmetic Innovations, following an inspection from June 3-6, 2019, at their Carrollton, Texas facility. The inspection revealed significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals (21 CFR, parts 210 and 211), rendering their drug products adulterated under section 501(a)(2)(B) of the FD&C Act.

Key violations include: 1. **Failure to test drug products prior to release (21 CFR 211.165(a)):** The firm released OTC topical drug products without adequate quality control testing, including identity and strength of active ingredients. Their proposed limited testing and lack of impurity profile data were deemed inadequate. 2. **Inadequate production and process control procedures (21 CFR 211.100(a)):** The firm lacked written control procedures for manufacturing processes and failed to validate processes for multiple drug products, including an ongoing monitoring program. Their proposed validation approach was insufficient in scope and statistical basis. 3. **Failure to test components for identity and validate supplier analyses (21 CFR 211.84(d)(1) and (2)):** The firm did not perform identity testing for each component, relying solely on supplier Certificates