BPI Labs LLC
Form 483 issued April 30, 2021 · Largo, Florida
- Inspection
- Apr 19 – Apr 30, 2021
- Investigators
- Emma R. Schaefer· Jessica L. Pressley· Saundrea A. Munroe
- Observations
- 5
- Pages
- 6
- FEI number
- 3015156709
In short: On April 30, 2021, FDA issued a Form 483 with 5 observations to BPI Labs LLC in Largo, Florida (FEI 3015156709) after an inspection that ran Apr 19 – Apr 30, 2021. The investigators were Emma R. Schaefer, Jessica L. Pressley and Saundrea A. Munroe. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.63 (equipment design, size, and location).
At a glance
Observations span 1 system, led by facilities & equipment.
Most cited: 21 CFR 211.63 (1×) · 21 CFR 4 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 02
Observation 2: scanned text, readable in the full document.
- 0321 CFR 4
Risk analysis is inadequate. Specifica lly, your firm's risk ana lysis conducted as part of the…
- 04
: Not…
This inspection in context
Emma R. Schaefer
4 documents · 2018–2021
Cites 820.50 (purchasing controls) more than any other section. Most of their documents are for sites in Illinois.
The firmBPI Labs LLC history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.63
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at BPI Labs LLC?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.63 (equipment design, size, and location). The opening words of each observation are shown on this page.
Who inspected BPI Labs LLC?
Emma R. Schaefer, Jessica L. Pressley and Saundrea A. Munroe are named on this Form 483, for the inspection of Apr 19 – Apr 30, 2021. Each investigator has a profile showing what they cite most.
When was BPI Labs LLC inspected by FDA?
The inspection ran Apr 19 – Apr 30, 2021, and the Form 483 is dated April 30, 2021.
How do I get the full Form 483 for BPI Labs LLC?
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.