Inspection Record

First Pharma Associates LLC dba Riverpoint Pharmacy — FDA 483 Findings

US FDAInspected 2017-02-17Published 2024-01-17 4 findingsEquipment and facilityValidation and qualificationOther quality systemEnvironmental monitoring

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

1Equipment and facility

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

2Validation and qualification

ISO 5 classified areas were not certified under dynamic conditions.

3Other quality system

The ISO 5 area is located within a non-classified room.

4Environmental monitoring

Sinks or drains are present in the cleanroom where the ISO 5 area is located.

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.

First Pharma Associates LLC dba Riverpoint Pharmacy company profile — full history US FDA documents, 2024 Go to Findings search