Findings
1Laboratory 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 firm performed chemical testing of drug products using high performance liquid chromatography (HPLC) but did not include complete data to support the analysis performed. In addition to chemical testing performed by a contract testing laboratory, our investigators determined that…
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, and to follow all of your written production and process control procedures (21 CFR 211.100(a) and 211.100 (b)). Lack of Process Validation You failed to provide data to demonstrate your drug manufacturing processes are adequately…
3Quality unit oversight
Your firm failed to establish and follow required laboratory control mechanisms (21 CFR 211.160(a)). The microbiological laboratory methods were inadequate to evaluate incoming bulk drug product, finished drug product, and monitor your (b)(4) system. In addition, our investigators found dirty glassware, and stoppers, and plates in incubation without unique sample identification numbers. In your response, you stated that trend analysis is part of your annual product review…
About this record
Extracted automatically from the document US FDA published on 2024-06-18. 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.
