Pfizer Pharmaceuticals LLC
Form 483 issued February 17, 2022 · Vega Baja, Puerto Rico
- Inspection
- Feb 7 – Feb 17, 2022
- Investigators
- Marian E. Ramirez· Miguel A. Martinez
- Observations
- 1
- Pages
- 4
- FEI number
- 2623619
In short: On February 17, 2022, FDA issued a Form 483 with 1 observation to Pfizer Pharmaceuticals LLC in Vega Baja, Puerto Rico (FEI 2623619) after an inspection that ran Feb 7 – Feb 17, 2022. The investigators were Marian E. Ramirez and Miguel A. Martinez. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.165(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
This inspection in context
Marian E. Ramirez
20 documents · 2016–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmPfizer Pharmaceuticals 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 211.165(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pfizer Pharmaceuticals LLC?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected Pfizer Pharmaceuticals LLC?
Marian E. Ramirez and Miguel A. Martinez are named on this Form 483, for the inspection of Feb 7 – Feb 17, 2022. Each investigator has a profile showing what they cite most.
When was Pfizer Pharmaceuticals LLC inspected by FDA?
The inspection ran Feb 7 – Feb 17, 2022, and the Form 483 is dated February 17, 2022.
How do I get the full Form 483 for Pfizer Pharmaceuticals 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.