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). A. Your investigations into rejected batches failed to extend to other batches, dosage strengths, and drug products for tablet compression machine settings. From 2018 to 2021, you rejected 14 batches of 0.1mg and 0.2mg strength desmopressin acetate…
2Laboratory and QC controls
Your firm failed to establish and follow required laboratory control mechanisms (21 CFR 211.160(a)). Your firm failed to have appropriate procedures for the integration of chromatographic peaks and for the review of chromatographic data processing. A. Our investigators identified an example of your firm manually entering timed integration events into the processing methods and reporting passing results without adequate procedural controls or justification. Your analyst…
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 process for (b)(4) gel (b)(4) %. Specifically, your process validation lacks an evaluation of inter-batch and intra-batch variability for (b)(4) gel (b)(4)…
4Documentation and records
Your firm failed to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced (21 CFR 211.188). Your batch records were incomplete and did not contain batch specific data for compression machine reject limits. Production operators acknowledged using default pre-set tablet rejection values in the recipes for tablet compression instead of calculating the batch specific rejection limits…
About this record
Extracted automatically from the document US FDA published on 2022-12-06. 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.
