BPI Labs
Form 483 issued June 12, 2019 · Evanston, Wyoming
- Inspection
- Jun 10 – Jun 12, 2019
- Investigator
- James R. Montero
- Observations
- 13
- Pages
- 10
- FEI number
- 3008875046
In short: On June 12, 2019, FDA issued a Form 483 with 13 observations to BPI Labs in Evanston, Wyoming (FEI 3008875046) after an inspection that ran Jun 10 – Jun 12, 2019. The investigator was James R. Montero. Most observations concern production & process controls and management controls.
At a glance
Production & process controls and management controls account for 8 of 13 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for monitoring and control of process parameters for a validated process…
- 02
Written MDR procedures have…
- 03
Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements…
- 04
Procedures for acceptance of incoming product…
This inspection in context
James R. Montero
10 documents · 2014–2025
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Utah.
The firmBPI Labs history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.75(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at BPI Labs?
FDA listed 13 observations on this Form 483, mostly about production & process controls, management controls and cAPA. The opening words of each observation are shown on this page.
Who inspected BPI Labs?
James R. Montero is named on this Form 483, for the inspection of Jun 10 – Jun 12, 2019. Each investigator has a profile showing what they cite most.
When was BPI Labs inspected by FDA?
The inspection ran Jun 10 – Jun 12, 2019, and the Form 483 is dated June 12, 2019.
How do I get the full Form 483 for BPI Labs?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.