Ultra Seal Corporation

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 establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)).

Passage 2

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 3

Your firm failed to adequately investigate out-of-specification (OOS) laboratory results and unexplained discrepancies. For example:

Passage 4

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 5

Your firm did not adequately investigate OOS laboratory results and unexplained discrepancies. You failed to appropriately justify potential root causes, expand investigations to all potentially affected lots, and implement CAPA.

Passage 6

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

Passage 7

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 8

Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products (21 CFR 211.22(a)).

Passage 9

Your firm failed to adequately exercise its responsibility to ensure that stability samples were tested at designated time points according to your SOP QA-65, “Stability System Procedure.” As a result, you lacked adequate data to ensure that drug products currently on the market maintain their identity, strength, quality, purity, and safety throughout their labeled shelf-lives.

Passage 10

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 drug manufacturer 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.