Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Failure to demonstrate that your manufacturing process can reproducibly manufacture an intermediate and API meeting its predetermined quality attributes.
Passage 2You failed to adequately validate your porcine thyroid API manufacturing processes, including the **(b)(4)** of **(b)(4)** intermediates. Additionally, the **(b)(4)** process validation was not representative of your current manufacturing process. For example:
Passage 3Failure to establish and follow written procedures for investigating critical deviations or the failure of intermediates and API lots to meet specifications.
Passage 4You failed to adequately investigate OOS results. For example:
Passage 5Failure to ensure that API lots meet specifications prior to blending with other lots.
Passage 6You failed to perform analytical testing prior to the final blend of **(b)(4)** intermediate lots. Your final blend consisted of up to **(b)(4)** intermediate lots. This practice may result in the blending of lots not meeting specifications and unreliable results reported for your finished API.
Passage 7Failure to address deviations may also cause FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any deviations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any deviations.