Inspection Record

Custom Compounding Center — FDA 483 Findings

US FDAInspected 2015-12-14Published 2024-01-17 3 findingsLaboratory and QC controlsAseptic processing and sterility assurance

Inspectors Joey V. QuitaniaThe inspectors who signed the published document.Inspector lookup

View the regulator's official source The source document is always the basis for judgement.

Findings

1Laboratory 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.

2Aseptic processing and sterility assurance

Aseptic processing areas are deficient regarding the system for monitoring environmental con ditions.

3Laboratory and QC controls

Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing .

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.

Other records for this company

2015-07-23 · US FDA · 6 findings2015-10-29 · US FDA · 14 findings
Custom Compounding Center company profile — full history US FDA documents, 2024 Go to Findings search