Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Failure to ensure that all specifications, sampling plans, test procedures are scientifically sound and appropriate to ensure that your API conform to established standards of quality and purity.
Passage 2Your firm did not perform verification studies for any test methods, including but not limited to identification, related substances by HPLC, residual solvent, and assay by HPLC for clomiphene citrate USP. For example, your firm failed to verify the residual solvent method used by your contract testing laboratory. Additionally, during the inspection, your QC manager confirmed that no method verification has been performed for any of the test methods used for clomiphene citrate USP.
Passage 3Failure to demonstrate that your manufacturing process can reproducibly manufacture an API meeting its predetermined quality attributes.
Passage 4Your firm failed to establish adequate process validation for clomiphene citrate USP and its key starting materials. Your process validation reports do not accurately reflect actual manufacturing practices. For example, your validation reports fail to address the **(b)(4)** operation. Also, your validations do not address routine hold times. For example, **(b)(4)** batch **(b)(4)** was stored for approximately **(b)(4)** without defined hold-time limits or supporting studies.
Passage 5Failure of your quality unit to exercise its responsibility to ensure the API manufactured at your facility are in compliance with CGMP.