Pfizer, Inc.
Form 483 issued February 18, 2025 · Rochester, Michigan
- Investigator
- Nicholas J. Presto
- Observations
- 8
- Pages
- 22
- FEI number
- 1876582
In short: On February 18, 2025, FDA issued a Form 483 with 8 observations to Pfizer, Inc. in Rochester, Michigan (FEI 1876582). The investigator was Nicholas J. Presto. Most observations concern quality system; the most-cited regulation is 21 CFR 211.198 (complaint files).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.198 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures describing the handling of written and oral complaints related to drug products are…
This inspection in context
Nicholas J. Presto
10 documents · 2023–2026
Cites 211.188 (batch production and control records) more than any other section. Most of their documents are for sites in Michigan.
The firmPfizer, Inc. history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.198
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pfizer, Inc.?
FDA listed 8 observations on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected Pfizer, Inc.?
Nicholas J. Presto is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Pfizer, Inc. inspected by FDA?
This Form 483 is dated February 18, 2025.
How do I get the full Form 483 for Pfizer, Inc.?
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.