1Laboratory and QC controls
Determinations of conformance to appropriate written specifications for acceptance are deficient for drug products.
Inspection Record
Atlas Pharmaceuticals, LLC — FDA 483 Findings
Inspectors Nicholas L HuntThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.
3Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic and sterilization process.
About this record
Extracted automatically from the document US FDA published on 2021-10-20. 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.
