Inspection Record

Vita Pharmacy, LLC dba Talon Compounding Pharmacy — FDA 483 Findings

US FDAInspected 2021-10-06Published 2021-12-22 3 findingsEquipment and facilityContamination controlValidation and qualification

Inspectors Camerson E MooreThe 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 facility design was observed to allow the influx of poor quality air into a higher classified area.

2Contamination control

Your fir m handled hazardous drug products without adequate containment, segregation, or cleaning of work surfaces and utensils to prevent cross-contamination.

3Validation and qualification

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

About this record

Extracted automatically from the document US FDA published on 2021-12-22. 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.

Vita Pharmacy, LLC dba Talon Compounding Pharmacy company profile — full history US FDA documents, 2021 Go to Findings search