Pfizer Pharmaceuticals LLC
FDA inspection history in Vega Baja, Puerto Rico, 2015 to 2022
- 4
- Form 483s
Every document, by year
- Form 483
2015: one Form 483; 2018: two Form 483s; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015One Form 483, at Vega Baja, Puerto Rico.
- 2015The longest 483 on file: 5 observations over 3 pages at Vega Baja, Puerto Rico.
- 2018Two Form 483s, at Vega Baja, Puerto Rico.
- 2022One Form 483, at Vega Baja, Puerto Rico.
Cited most
Across all Pfizer Pharmaceuticals observations on file
- 21 CFR 211.160General requirements2
- 21 CFR 211.192Production record review2
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
- 21 CFR 211.165(a)Testing and release for distribution1
- 21 CFR 211.182Equipment cleaning and use log1
The complete Pfizer Pharmaceuticals file.
All 4 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Vega Baja, Puerto Rico
Four Form 483s · 2015 to 2022 · 8 observations
Latest: Form 483, Feb 17, 2022 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-02-17 | 483 Form 483 | Vega Baja, Puerto Rico | 1 | $99 |
| 2018-01-26 | 483 Form 483 | Vega Baja, Puerto Rico | 1 | $99 |
| 2018-01-26 | 483 Form 483 | Vega Baja, Puerto Rico | 1 | $99 |
| 2015-06-19 | 483 Form 483 | Vega Baja, Puerto Rico | 5 | $99 |
Investigators on these documents
Marian E. Ramirez (3)Jose Velez (2)Chelsea N. Sealey (1)Miguel A. Martinez (1)Noreen Muniz (1)
FEI number 2623619 · most recent document Feb 17, 2022
About Pfizer Pharmaceuticals LLC
How many FDA Form 483s has Pfizer Pharmaceuticals LLC received?
FDA Intel has 4 Form 483s on file for Pfizer Pharmaceuticals LLC; the most recent is dated Feb 17, 2022.
When was Pfizer Pharmaceuticals LLC last inspected by FDA?
The most recent FDA inspection document on file for Pfizer Pharmaceuticals LLC is a Form 483 dated Feb 17, 2022, for the site in Vega Baja, Puerto Rico.
What did FDA cite at Pfizer Pharmaceuticals LLC?
The regulations cited most in the observations on file for Pfizer Pharmaceuticals LLC are 21 CFR 211.160 (General requirements), 2 times; 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.110 (Sampling and testing of in-process materials and drug products), 1 time.