Inspection Record

BPI Labs LLC — FDA 483 Findings

US FDAInspected 2021-04-30Published 2022-05-31 3 findingsOther quality systemEquipment and facilityMaterial and supplier control

Inspectors Emma R Schaefer · Jessica L Pressley · Saundrea A MunroeThe inspectors who signed the published document.Inspector lookup

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

Findings

1Other quality system

Not annotated SEE REVERS E OF THIS PAGE

2Equipment and facility

Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.

3Material and supplier control

Potential suppliers were not evaluated and selected based on their ability to meet specified requirements.

About this record

Extracted automatically from the document US FDA published on 2022-05-31. 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.

Other records for this company

2026-04-17 · US FDA · 4 findings
BPI Labs LLC company profile — full history US FDA documents, 2022 Go to Findings search