Pfizer, Inc.
Form 483 issued July 23, 2015 · Rochester, Michigan
- Investigators
- Emily J. Orban· Rebecca E. Dombrowski
- Observations
- 2
- Pages
- 1
- FEI number
- 1876582
In short: On July 23, 2015, FDA issued a Form 483 with 2 observations to Pfizer, Inc. in Rochester, Michigan (FEI 1876582). The investigators were Emily J. Orban and Rebecca E. Dombrowski. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and production account for 2 of 2 observations.
Most cited: 21 CFR 211.22 (1×) · 211.111 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Time limits are not established when appropriate for the completion of each production phase to assure…
This inspection in context
Emily J. Orban
19 documents · 2012–2020
Cites 211.42 (design and construction features) 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
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pfizer, Inc.?
FDA listed 2 observations on this Form 483, mostly about quality system and production. 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.?
Emily J. Orban and Rebecca E. Dombrowski are 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 July 23, 2015.
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.