1Equipment and facility
Procedures describing the calibration of instruments, apparatus, gauges and recording devices are not written or followed.
Inspection Record
Advanced Pharma Inc. — FDA 483 Findings
Inspectors Stephen D BrownThe 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 a re not established · Specifically, A) Your firm uses non-sterile (b)(4 ) and Sterile (b) (4 ) for the sanitation of the interior of th e (b)(4) ISO 5 Laminar Air Flow hoods.
3Laboratory and QC controls
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the identity and strength of each active ingredient prior to release.
4Aseptic processing and sterility assurance
Test procedures relative to appropriate laboratory testing for sterility and pyrog ens are not written.
5Labeling and packaging
The labels of your outsourcing facility's drug products are deficient.
About this record
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.
