BPI Labs
Form 483 issued March 10, 2022 · Evanston, Wyoming
- Inspection
- Mar 7 – Mar 10, 2022
- Investigator
- Alan P. Kurtzberg
- Observations
- 12
- Pages
- 6
- FEI number
- 3008875046
In short: On March 10, 2022, FDA issued a Form 483 with 12 observations to BPI Labs in Evanston, Wyoming (FEI 3008875046) after an inspection that ran Mar 7 – Mar 10, 2022. The investigator was Alan P. Kurtzberg. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Production and quality system account for 8 of 12 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are…
- 02
The batch production and control records are deficient in that they do not include the identity…
- 03
Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate…
- 04
There are no written procedures for production and process controls designed to assure that the drug…
This inspection in context
Alan P. Kurtzberg
24 documents · 2015–2023
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
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 211.113(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at BPI Labs?
FDA listed 12 observations on this Form 483, mostly about production, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected BPI Labs?
Alan P. Kurtzberg is named on this Form 483, for the inspection of Mar 7 – Mar 10, 2022. Each investigator has a profile showing what they cite most.
When was BPI Labs inspected by FDA?
The inspection ran Mar 7 – Mar 10, 2022, and the Form 483 is dated March 10, 2022.
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.