Pfizer, Inc.
Form 483 issued October 21, 2019 · Rochester, Michigan
- Inspection
- Oct 15 – Oct 21, 2019
- Investigator
- Jacob G. Lutz
- Observations
- 1
- Pages
- 2
- FEI number
- 1876582
In short: On October 21, 2019, FDA issued a Form 483 with 1 observation to Pfizer, Inc. in Rochester, Michigan (FEI 1876582) after an inspection that ran Oct 15 – Oct 21, 2019. The investigator was Jacob G. Lutz. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22(d) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Jacob G. Lutz
14 documents · 2019–2024
Cites 211.22 (responsibilities of quality control unit) 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 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pfizer, Inc.?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Pfizer, Inc.?
Jacob G. Lutz is named on this Form 483, for the inspection of Oct 15 – Oct 21, 2019. Each investigator has a profile showing what they cite most.
When was Pfizer, Inc. inspected by FDA?
The inspection ran Oct 15 – Oct 21, 2019, and the Form 483 is dated October 21, 2019.
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.