Inspection Record
Inspectors Robert J Martin · Erik W KoesterThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications and identity and strength of each active ingredient prior to release.
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed.
Each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
Equipment for adequate control over air pressme and micro-organisms is not provided when appropriate for the manufacture, processing, packing or holding of a drug product.
Procedures describing the handling of all written and oral complaints regarding a drug product are not written.
Extracted automatically from the document US FDA published on 2024-01-17. 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.
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