Inspection Record

Buffalo Pharmacies Inc. — FDA 483 Findings

US FDAInspected 2017-08-21Published 2024-01-17 5 findingsAseptic processing and sterility assuranceTraining and personnelEquipment and facility

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

Findings

1Aseptic processing and sterility assurance

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.

2Training and personnel

Clothing of personnel engaged in the processing of drug products is no t appropriate for the duties the y perform.

3Equipment and facility

Adequate ventilation is not provided.

4Aseptic processing and sterility assurance

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

5Equipment and facility

Routine calibration and inspection of mechanical and electronic equipment is not performed according to a written program designed to assure proper performance.

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.

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