Inspection Record

Specialty Compounding Pharmacy — FDA 483 Findings

US FDAInspected 2015-07-10Published 2024-01-17 4 findingsAseptic processing and sterility assuranceStability and storage

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Findings

1Aseptic processing and sterility assurance

Procedures designedto prevent microbiological contamination of drug products purporting to be sterile are not established.

2Aseptic processing and sterility assurance

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

3Aseptic processing and sterility assurance

Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipmentto produce aseptic conditions.

4Stability and storage

There is no written testing program designed to assess the stability characteristics of drug products.

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.

Specialty Compounding Pharmacy company profile — full history US FDA documents, 2024 Go to Findings search