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 thyroid, USP API manufacturing processes. Specifically, there were several processing steps prior to the final blend, such as **(b)(4)**, and **(b)(4)**, that you did not include in your process validation. Your quality unit personnel stated that you planned to validate these processes in the future.
Passage 3Failure to ensure that, for each batch of intermediates and API, appropriate laboratory tests are conducted to determine conformance to specifications.
Passage 4You failed to perform laboratory testing to ensure that the thyroid, USP API lots held for extended periods of time met all quality attributes prior to blending into your final API blend. For example, lot **(b)(4)**, tested February 5, 2019, was blended, without retest, into finished thyroid, USP API, lot B20361-FS on February 15, 2021. Your quality unit personnel stated that your firm did not have retest requirements or procedures for lots prior to the final blend.
Passage 5Failure to exercise sufficient controls over computerized systems to prevent unauthorized access or changes to data, and failure to have adequate controls to prevent omission of data.
Passage 6Failure to ensure that all test procedures are scientifically sound and appropriate to ensure that your intermediate and API conform to established standards of quality.
Passage 7Failure of your quality unit to exercise its responsibility to ensure the API and intermediates manufactured at your facility are in compliance with CGMP.
Passage 8Failure 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.