Missouri Analytical Laboratories Inc

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).

Passage 2

Your firm failed to thoroughly investigate unexplained discrepancies and out-of-specification (OOS) results. In addition, investigations were closed without adequate scientific justification. For example,

Passage 3

Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records (21 CFR 211.68(b)).

Passage 4

Your firm did not have adequate system security and access control for the **(b)(4)** system. For example, unique user accounts and privilege levels were not assigned to individual users for **(b)(4)** software, and the Windows operating system. The analysts had access to delete and overwrite data. Our investigators found approximately 36 deleted data files or folders in the recycle bin.

Passage 5

Failure to document and explain any deviation and investigate all critical deviations.

Passage 6

Failure to address violations and deviations may also cause FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your facility as a drug manufacturer until any violations and 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 violations and deviations.