Inspection Record

Colonia Care Pharmacy — FDA 483 Findings

US FDAInspected 2016-08-16Published 2024-01-17 5 findingsLaboratory and QC controlsAseptic processing and sterility assuranceStability and storage

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 final specifications and 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 conditions.

3Stability and storage

Container closure systems do not provide adequate protection against foreseeable external factors in storage and.

4Stability and storage

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

5Aseptic processing and sterility assurance

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include validation of the sterilization process.

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

2021-07-26 · US FDA · 3 findings
Colonia Care Pharmacy findings history — including this company's other documents US FDA documents, 2024 Go to Findings search