Your firm failed to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance (21 CFR 211.63). Equipment used in the manufacture of terminally sterilized drugs at your facility is not designed or maintained appropriately. Our inspection revealed instances of damaged metal and plastic parts, open vials…
2Deviation, 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). You failed to conduct adequate investigations into endotoxin testing and your 100% automated visual inspection system. You conducted investigations that were not thorough, expanded to an appropriate scope, or based on scientifically supported root…
3Equipment and facility
Your firm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)). An FDA investigator observed white spots at the bottom of a (b)(4) L bulk solution holding tank used to supply a non-dedicated filling machine despite the vessel being documented as clean. You subsequently analyzed and identified the white spots as (b)(4) (the product previously processed on this equipment) at levels of up to (b)(4) parts per…
4Aseptic processing and sterility assurance
Your firm failed to establish adequate written procedures for production and process control designed to assure that 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 (b)). Your program for the visual inspection of sterile injectable drug products does not provide adequate assurance that finished products…
About this record
Extracted automatically from the document US FDA published on 2023-08-01. 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.
