Adamson 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 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 2

Your firm failed to establish and follow required laboratory control mechanisms (21 CFR 211.160(a)).

Passage 3

You failed to adequately control critical changes to electronic laboratory monitoring operations using documentation, assessment, and approval of the QU. Specifically, critical changes to laboratory operations without QU oversight included, but are not limited to, the following:

Passage 4

Failure to address violations may also cause FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a contract testing laboratory until any violations 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.