FDA WARNING_LETTER - FLOWCHEM PHARMA PRIVATE LIMITED - September 12, 2025

The FDA issued a Warning Letter to Flowchem Pharma Private Limited following an inspection of their drug manufacturing facility in Andhra Pradesh, India, conducted from September 8 to 12, 2025. The inspection identified significant deviations from Current Good Manufacturing Practice (CGMP) for active pharmaceutical ingredients (APIs), deeming their products adulterated under the Federal Food, Drug, and Cosmetic Act.

Key issues included the failure to adequately clean manufacturing equipment, with investigators observing residues and rust on surfaces marked as clean. Additionally, the company failed to properly handle and store raw materials, evidenced by open and exposed API-containing bags and visibly contaminated solutions. The firm also neglected to establish comprehensive impurity profiles for APIs, did not validate testing methods for organic impurities, and failed to properly qualify secondary reference standards. Lastly, Flowchem Pharma did not perform identity testing on each incoming raw material batch, relying instead on unverified supplier Certificates of Analysis.

The FDA emphasized that the company"s quality unit lacked sufficient authority and recommended engaging a qualified consultant to perform a comprehensive six-system audit to ensure CGMP compliance. Flowchem Pharma is required to implement robust corrective and preventive action (CAPA) plans addressing equipment cleaning, material management, laboratory controls, impurity assessment, and supplier qualification, with a response due within 15 working days. Non-compliance may lead to continued import refusal under Import Alert 66-40.