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 firm failed to perform a thorough investigation after being informed that FDA testing found OOS assay results for one lot of (b)(4) tablets. You manufacture (b)(4) tablets under contract for the product owner, (b)(4) . In the quality agreement with…
2Material and supplier control
Your firm failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)). Your stability program is inadequate. You failed to have adequate long-term stability data to support the commercial size validation batches manufactured using API from a new supplier. Also, you failed to…
3Process 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)). Your firm failed to adequately validate the manufacturing processes for your (b)(4) tablets. You lacked adequate data to show homogeneity of your drug product during manufacturing . During your process performance…
4Quality unit oversight
Your 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). Your quality unit (QU) failed to adequately oversee the quality of components received from your supplier and your drug manufacturing operations. For example: • The variability in API assay results reported by your supplier compared to your…
About this record
Extracted automatically from the document US FDA published on 2021-02-09. 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.
