Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Failure 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.
Passage 2Failure to ensure that materials are handled and stored in a manner to prevent degradation, contamination, and cross-contamination.
Passage 3Failure 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.
Passage 4You 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 specification for these impurities. Chromatograms from your unvalidated method showed unknown, unintegrated impurities that were not quantified. As a result, these peaks were not fully considered when making your release decisions.
Passage 5Failure to test the identity of each batch of incoming production material and appropriately qualify suppliers to rely upon their Certificate of Analysis.
Passage 6You 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.