Findings
1Quality unit oversight
Your firm failed to establish an adequate quality unit and the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed (21 CFR 211.22(a) and 211.22(d)). Your quality unit (QU) lacked adequate control over your testing operations and failed to ensure that you had suitable procedures. For example, your QU failed: To adequately retain documentation for the review, approval, or rejection, of laboratory testing materials such…
2Laboratory and QC controls
Your firm failed to follow required laboratory control mechanisms and to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(a) and 211.160(b)). You failed to adequately…
3Laboratory and QC controls
Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards (21 CFR 211.194(a)). Your laboratory records do not include complete testing data to support the analysis performed. For example, your records lack a statement of methods used for testing, a statement of the results of tests and how they compare to the established specifications, a record of all critical…
About this record
Extracted automatically from the document US FDA published on 2023-05-23. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
