Inspection Record

First Call Pharmacy, LLC — FDA 483 Findings

US FDAInspected 2017-09-12Published 2024-01-17 4 findingsAseptic processing and sterility assuranceEnvironmental monitoringEquipment and facility

Inspectors Francis GuidryThe 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

Personnel engaged in a septic processing were observed with exposed mouth.

2Environmental monitoring

The use of sporicidal agents in the cleanrooms and/or ISO 5 area is inadequate or infrequent.

3Aseptic processing and sterility assurance

Personnel engaged in aseptic processing were observed with exposed hands.

4Equipment and facility

The facility is designed and/or operated in a way that permits poor flow of materials.

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 Call Pharmacy, LLC company profile — full history US FDA documents, 2024 Go to Findings search