Pfizer Manufacturing Deutschland GmbH
Form 483 issued February 7, 2020 · Freiburg im Breisgau, Germany
- Inspection
- Feb 3 – Feb 7, 2020
- Investigator
- Niketa Patel
- Observations
- 3
- Pages
- 2
- FEI number
- 3002807097
In short: On February 7, 2020, FDA issued a Form 483 with 3 observations to Pfizer Manufacturing Deutschland GmbH in Freiburg im Breisgau, BW (FEI 3002807097) after an inspection that ran Feb 3 – Feb 7, 2020. The investigator was Niketa Patel. Most observations concern quality system and production.
At a glance
2 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The quality control unit lacks responsibility to approve and reject all specifications impacting on the identity…
- 02
There are no written procedures for production and process controls designed to assure that the drug…
- 03
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
This inspection in context
Niketa Patel
15 documents · 2016–2023
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in New Jersey.
The firmPfizer Manufacturing Deutschland GmbH history
All 2 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 Manufacturing Deutschland GmbH?
FDA listed 3 observations on this Form 483, mostly about quality system and production. The opening words of each observation are shown on this page.
Who inspected Pfizer Manufacturing Deutschland GmbH?
Niketa Patel is named on this Form 483, for the inspection of Feb 3 – Feb 7, 2020. Each investigator has a profile showing what they cite most.
When was Pfizer Manufacturing Deutschland GmbH inspected by FDA?
The inspection ran Feb 3 – Feb 7, 2020, and the Form 483 is dated February 7, 2020.
How do I get the full Form 483 for Pfizer Manufacturing Deutschland GmbH?
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.