Pfizer, Inc.
Form 483 issued November 21, 2016 · Rochester, Michigan
- Inspection
- Nov 14 – Nov 21, 2016
- Investigators
- Aurora-Miha Trifanov· Emilie Kahn· Emily J. Orban
- Observations
- 2
- Pages
- 4
- FEI number
- 1876582
In short: On November 21, 2016, FDA issued a Form 483 with 2 observations to Pfizer, Inc. in Rochester, Michigan (FEI 1876582) after an inspection that ran Nov 14 – Nov 21, 2016. The investigators were Aurora-Miha Trifanov, Emilie Kahn and Emily J. Orban. Most observations concern production and materials; the most-cited regulation is 21 CFR 211.111 (time limitations on production).
At a glance
Production and materials account for 2 of 2 observations.
Most cited: 21 CFR 211.111 (1×) · 211.80(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Time limits are not established when appropriate for the completion of each production phase to assure…
- 02
Written procedures are not followed for the receipt, identification, storage, handling and approval of components…
This inspection in context
Aurora-Miha Trifanov
2 documents · 2016–2020
Cites 211.111 (time limitations on production) 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 211.111
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 production and materials. The most-cited regulation is 21 CFR 211.111 (time limitations on production). The opening words of each observation are shown on this page.
Who inspected Pfizer, Inc.?
Aurora-Miha Trifanov, Emilie Kahn and Emily J. Orban are named on this Form 483, for the inspection of Nov 14 – Nov 21, 2016. Each investigator has a profile showing what they cite most.
When was Pfizer, Inc. inspected by FDA?
The inspection ran Nov 14 – Nov 21, 2016, and the Form 483 is dated November 21, 2016.
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.