Findings
1Laboratory and QC controls
Your firm failed to establish adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)). Your cleaning processes for drug manufacturing equipment, including those used for blister card and liquid repacking operations, were inadequate. For example, your quality control checks failed to identify contaminated surfaces of your (b)(4) blister card packaging equipment. You also noted multiple occurrences of visibly contaminated tablets and capsules…
2Process validation
Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)). You failed to provide adequate data to demonstrate you validated your drug packaging processes to ensure consistent product quality. For example, you packaged and distributed various drug products which lacked…
3Equipment and facility
Your firm failed to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups (21 CFR 211.42(c)). Your facility design is inadequate to prevent cross-contamination. You repackage non-penicillin beta-lactam drugs in the same facility as non-beta-lactam drugs, rather than in separate dedicated facilities. Complete and comprehensive separation of beta-lactam repackaging operations is essential due to the severe patient risk posed…
4Deviation, CAPA, and investigation
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). Your investigations lacked sufficient root cause determinations, CAPA, and assessment of all potentially affected batches. For example, you identified multiple deviations for numerous broken tablets caused by your packaging equipment between October 20…
About this record
Extracted automatically from the document US FDA published on 2023-06-06. 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.
