Pfizer, Inc.
FDA inspection history across 2 sites, 2002 to 2025
- 4
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2002: one warning letter; 2015: one Form 483; 2016: one Form 483; 2019: one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2002One warning letter, at New York, New York.
- 2015–16Two Form 483s, at Rochester, Michigan.
- 2019One Form 483, at Rochester, Michigan.
- 2025One Form 483, at Rochester, Michigan.
- 2025The longest 483 on file: 8 observations over 22 pages at Rochester, Michigan.
Cited most
Across all Pfizer observations on file
- 21 CFR 211.111Time limitations on production2
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 211.198Complaint files1
- 21 CFR 211.80(a)General requirements1
The complete Pfizer file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Rochester, Michigan
Four Form 483s · 2015 to 2025 · 13 observations
Latest: Form 483, Feb 18, 2025 →New York, New York
One warning letter · 2002
Latest: Warning letter, Jan 30, 2002 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-02-18 | 483 Form 483 | Rochester, Michigan | 8 | $99 |
| 2019-10-21 | 483 Form 483 | Rochester, Michigan | 1 | $99 |
| 2016-11-21 | 483 Form 483 | Rochester, Michigan | 2 | $99 |
| 2015-07-23 | 483 Form 483 | Rochester, Michigan | 2 | $99 |
| 2002-01-30 | Warning letter Warning letter | New York, New York | — | $99 |
Investigators on these documents
Emily J. Orban (2)Aurora-Miha Trifanov (1)Emilie Kahn (1)Jacob G. Lutz (1)Nicholas J. Presto (1)Rebecca E. Dombrowski (1)
FEI number 1876582 · most recent document Feb 18, 2025
About Pfizer, Inc.
How many FDA Form 483s has Pfizer, Inc. received?
FDA Intel has 4 Form 483s on file for Pfizer, Inc.; the most recent is dated Feb 18, 2025.
When was Pfizer, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Pfizer, Inc. is a Form 483 dated Feb 18, 2025, for the site in Rochester, Michigan.
What did FDA cite at Pfizer, Inc.?
The regulations cited most in the observations on file for Pfizer, Inc. are 21 CFR 211.111 (Time limitations on production), 2 times; 21 CFR 211.22 (Responsibilities of quality control unit), 2 times; 21 CFR 211.198 (Complaint files), 1 time.
Has Pfizer, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Pfizer, Inc.; the most recent is dated Jan 30, 2002.