Findings
1Aseptic processing and sterility assurance
Your firm failed to have buildings used in the manufacture, processing, packing, or holding of drug products of a suitable size, construction, and location to facilitate cleaning, maintenance, and proper operations (21 CFR 211.42(a)). Your firm also failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas, and an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions (21 CFR…
2Laboratory and QC controls
Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)). Our investigators observed inadequately controlled laboratory reagents (i.e., inadequate…
3Aseptic processing and sterility assurance
Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)). Your firm manufactures sterile radiopharmaceutical drug products that are aseptically filled. You failed to have appropriate gowning for aseptic production of sterile injectable drug products. For example…
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.
