Inspection Record
View the regulator's official source The source document is always the basis for judgement.
Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process.
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the to produce aseptic conditions.
Extracted automatically from the document US FDA published on 2025-09-12. 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.
Growth stages previewSolve a quiz to start hatching
Your growth record is stored safely in this browser.
