Flowchem Pharma Private Limited — FDA Warning Letter Findings

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. Your firm manufactures (b)(4) API intended for the U.S. market. You lacked adequate procedures for cleaning and maintenance of manufacturing equipment. FDA documented an unidentified (b)(4) residue, apparent rust, and unidentified liquids inside or on product contact…

Failure to test the identity of each batch of incoming production material and appropriately qualify suppliers to rely upon their Certificate of Analysis. You failed to conduct an identity test on each lot of raw material used in the manufacture of your API. You instead relied on the certificates of analysis (COAs) from your supplier without adequately qualifying them. For example, you accepted (b)(4) raw material without performing identity testing or performing vendor…

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 that your API conform to established standards of quality and purity. You failed to conduct a comprehensive evaluation of your manufacturing processes to identify potential impurities. For example, you did not validate your method for testing for organic impurities in (b)(4) API, nor did you have a…

Failure to ensure that materials are handled and stored in a manner to prevent degradation, contamination, and cross-contamination. Your firm did not adequately prevent contamination of materials and intermediates. For example, you stored bags of raw materials outside your facility without adequate protection. Our investigators observed multiple bags of material, containing API, that were open and exposed to the environment. These bags were observed adjacent to an area…