FDA WARNING_LETTER - Essnd Global - September 13, 2019

The FDA inspected Essnd Global's drug manufacturing facility in Sinnare, Nashik, India, from September 9-13, 2019, identifying significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B). The firm failed to respond to initial observations. Key violations include the failure to perform appropriate laboratory testing for each drug product batch, specifically for identity, strength of active ingredients, and objectionable microorganisms, prior to release (21 CFR 211.165(a) and (b)). Additionally, the firm failed to adequately test incoming components for identity, purity, strength, and quality, and did not validate supplier's test analyses (21 CFR 211.84(d)(1) and (2)), including insufficient monitoring of their water system. A critical deficiency was the failure to establish an adequate quality unit and ensure written procedures for quality functions like stability studies, OOS investigations, and product release were followed (21 CFR 211.22(a) and (d)). The FDA requires comprehensive corrective actions, including full chemical and microbiological testing of retain samples, robust component testing procedures, and a remediation plan for the quality unit, with a response due within 15 working days. The firm was placed on Import Alert 66-40, and FDA may withhold approvals or refuse admission of products. Engaging a qualified CGMP consultant is strongly recommended.