Glossary
Quality Control (QC)
Setting specifications, sampling, testing, and approving so that materials, intermediates, packaging materials, and finished products conform to the defined specifications.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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Per your response, you initiated CAPA-HOU-025-009 but did not provide an update detailing your assessment of procedures HOU-QC-005, HOU-QC-009, and HOU-QC-014.
FDA · FDA Warning Letter · 2025-11-25 -
Failure to withhold from use each lot of components, drug product containers, and closures until the lot has been sampled, tested, or examined, as appropriate, and released for use by the quality control unit [21 CFR 211.84(a)].
FDA · FDA Warning Letter · 2022-02-22 -
You firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).
FDA · FDA Warning Letter · 2022-06-28
