Drugs

API Deviations Seen in Flowchem Pharma Inspection

A 9/8-9/12/2025 FDA inspection at the Flowchem Pharma Private Limited drug manufacturing facility in Hindupur Taluk, Andhra Pradesh, India, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs). A 3/11 Warning Letter says the specific deviations were:

failure to clean equipment and utensils to prevent contamination or carry-over of a material that would alter the quality of the intermediates and API beyond the official or other established specifications;
failure to ensure that materials are handled in a manner to prevent degradation, contamination, and cross-contamination;
failure to establish an impurity profile for identified and unidentified impurities and failure to ensure all test procedures are scientifically sound and appropriate to ensure the API conforms to established standards of quality and purity; and
failure to test the identity of each batch of incoming production material and appropriately qualify suppliers to rely upon their Certificate of Analysis.

FDA says significant findings in the letter indicate that the firm’s quality unit is not fully exercising its authority and/or responsibilities. It recommends that Flowchem engage a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements. The consultant should also perform a six-system audit of the firm’s entire operation for CGMP compliance and evaluate the completion and efficacy of its corrective and preventive actions, the agency says.

All of Flowchem’s drugs and drug products offered for import into the U.S. were placed on a 1/22 Import Alert.

The company was told to correct the deviations promptly and to respond with a list of specific steps it has taken to address the deviations and prevent their recurrence, with a schedule for completing the corrections.

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