Inspection Record

Kelley-Ross Compounding Pharmacy — FDA 483 Findings

US FDAInspected 2017-09-12Published 2024-01-17 7 findingsAseptic processing and sterility assuranceEnvironmental monitoringEquipment and facilityValidation and qualificationContamination control

Inspectors Gerard P. De LeonThe inspectors who signed the published document.Inspector lookup

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

Findings

1Aseptic processing and sterility assurance

Media fills were not performed that closely simulate aseptic production operations incorporating, as appropriate, worst-case activities and conditions that provide a challenge to aseptic operations.

2Environmental monitoring

Sporicidal agents are not used in your facility's cleanroom.

3Aseptic processing and sterility assurance

Equipment, materials, and/or supplies are not disinfected prior to entering the aseptic processing areas.

4Equipment and facility

The ISO-classified areas have difficult to clean, particle-generating, or visibly dirty equipment.

5Validation and qualification

IS0-5 classified areas were not certified under dynamic conditions.

6Aseptic processing and sterility assurance

Environmental monitoring was not performed in your aseptic processing areas.

7Contamination control

Non-microbial contamination was observed in your production area.

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

2017-08-29 · US FDA · 3 findings
Kelley-Ross Compounding Pharmacy findings history — including this company's other documents US FDA documents, 2024 Go to Findings search