Seatex, LLC
5 extracted findings
FDA source excerpt, selected passage
Your firm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)).
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
Findings extracted from the letter
Selected FDA passages, not the complete letter.
01
Your firm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)).
Source passage selected by the model
02
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).
Source passage selected by the model
03
Your firm did not adequately investigate out-of-specification (OOS) results. Specifically, your practice to test a new sample if the original result fails, until either a **(b)(4)** failing result or a passing result is obtained, is not scientifically justified. Additionally, your firm does not record or retain the OOS test results for review or investigation. You also could not provide a procedure or policy governing retesting following an OOS result.
Source passage selected by the model
04
Your firm failed to conduct at least one test to verify the identity of each component of a drug product. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)).
Source passage selected by the model
05
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.
Source passage selected by the model
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.