FDA WARNING_LETTER - Global Treat Srl - September 13, 2019

The FDA inspected Global Treat SRL in Romania from September 9-13, 2019, uncovering significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering its “HemoTreat Hemorrhoid Ointment” adulterated and an unapproved new drug. Key deficiencies included: 1) Failure to perform adequate laboratory testing for identity and strength of active ingredients for each drug product batch prior to release (21 CFR 211.165(a)). 2) Failure to test incoming components for identity, purity, strength, and quality, and to validate supplier Certificates of Analysis (21 CFR 211.84(d)(1) and (2)). 3) Failure to establish an adequate Quality Control Unit (QU), with responsibilities not fully followed, resulting in insufficient oversight of manufacturing, record review, and complaint handling (21 CFR 211.22(a) and (d)). Furthermore, “HemoTreat Hemorrhoid Ointment” is an unapproved new drug (21 U.S.C. 355(a)) as its formulation, specifically adeps suillus, does not comply with the OTC anorectal drug product final rule (21 CFR 346). The firm’s initial response was inadequate. FDA demands comprehensive corrective actions, including detailed plans for testing retain samples, independent laboratory assessment, material system review, and QU remediation. Global Treat SRL was placed on Import Alert 66-40, with potential for continued import refusal and withheld drug approvals if violations persist. A CGMP consultant was strongly recommended.