FDA WARNING_LETTER - TG United, Inc. - February 15, 2019

The FDA inspected TG United, Inc.'s drug manufacturing facility from December 17, 2018, to February 15, 2019, identifying significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated. Additionally, the firm manufactures and markets ten unapproved new drugs, including HISTEX PD Drops and Rynex DM, which violate section 505(a) of the FD&C Act because their labeling for children under six years of age does not comply with the OTC cough/cold final rule (21 CFR 341). CGMP deficiencies include a failure to thoroughly investigate unexplained discrepancies, out-of-specification (OOS) results, and water system monitoring failures (21 CFR 211.192). The firm also failed to ensure equipment, specifically the (b)(4) water systems, was of appropriate design and adequately controlled (21 CFR 211.63), and failed to adequately clean and maintain shared equipment (21 CFR 211.67(a)). Furthermore, the stability testing program was inadequate, lacking validated test methods for impurities (21 CFR 211.166(a)). Many of these CGMP violations are repeat observations from prior inspections dating back to 2010, indicating a systemic lack of executive management oversight. The FDA strongly recommends engaging a qualified CGMP consultant. The firm must respond within 15 working days with corrective actions and a timeline, or face potential legal action, including seizure, injunction, and impact on drug approvals and export certificates.