Inspection Record

Bayview Pharmacy Inc. — FDA 483 Findings

US FDAInspected 2018-05-22Published 2024-01-17 3 findingsAseptic processing and sterility assuranceContamination controlEquipment and facility

Inspectors Edmund F. Mrack Jr. · Nealie C. NewbergerThe 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

Disinfecting agents Used in the ISO S area [aseptic processing areas] are not sterile.

2Contamination control

Highly potent drugs were produced without providing adequate containment, segregation, and/or cleaning of work surfaces, utensils, and/or personnel to prevent cross-contamination.

3Equipment and facility

The facility design was observed to allow the influx of poor quality air into a higher classified 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.

Bayview Pharmacy Inc. company profile — full history US FDA documents, 2024 Go to Findings search