1Contamination control
Non-microbial contamination was observed in your production area.
Inspection Record
Barclay, Luke, & Pillai Specialty Pharmacy, PLLC — FDA 483 Findings
Inspectors Christopher R CzajkaThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Material and supplier control
The identity of each component of a drug product is not verified by conducting at least one test to verify the identity, using specific identity tests if they exist.
3Aseptic processing and sterility assurance
Media fills do not adequately simulate the most challenging or stressful conditions.
4Aseptic processing and sterility assurance
The ISO 5 classified aseptic processing areas had difficult to clean and visibly dirty equipment or surface.
5Laboratory 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.
6Environmental monitoring
Unsealed, loose ceiling tiles were observed in your cleanroom.
7Contamination control
You produced hazardous drugs without providing adequate containment to prevent cross-contamination.
About this record
Extracted automatically from the document US FDA published on 2023-02-23. 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.
