FDA WARNING_LETTER - Suhan Aerosol - August 08, 2023

The FDA issued a Warning Letter to Suhan Aerosol, an OTC drug product manufacturer in India, after reviewing records submitted under Section 704(a)(4) of the FD&C Act. The review identified significant Current Good Manufacturing Practice (CGMP) violations, leading to the classification of the firm's drug products as adulterated under 21 U.S.C. 351(a)(2)(B). Key deficiencies include the firm's failure to conduct identity testing for each component of a drug product, specifically high-risk components like glycerin, propylene glycol, and sorbitol solution, to verify the absence of diethylene glycol (DEG) or ethylene glycol (EG) contamination, as required by 21 CFR 211.84(d)(1). Furthermore, the firm failed to establish an adequate quality control unit with the necessary authority to approve or reject all components and materials, indicating a lack of effective oversight over manufacturing operations (21 CFR 211.22(a)). The FDA recommends engaging a qualified CGMP consultant to evaluate operations and perform a comprehensive six-system audit. The firm was placed on Import Alert 66-40 and must respond within 30 working days detailing corrective actions. Failure to address these violations may result in FDA withholding approval of new applications or export certificates.