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Pfizer Manufacturing Deutschland GmbH — FDA Facility Profile

FEI 3002807097

Pfizer Manufacturing Deutschland GmbH is an FDA-registered facility (FEI 3002807097) located in Freiburg im Breisgau, BW, DE. Registered operations: ANALYSIS; LABEL; MANUFACTURE; PACK. RegDataLab tracks 8 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Jul 2, 2025: Voluntary Action Indicated (VAI)
Inspections on record
8 (6 VAI, 2 NAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Recalls as the recalling firm
1, latest Sep 27, 2017
Import refusals
10 or more

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Jul 2, 2025Voluntary Action Indicated (VAI)No citations listed
May 11, 2023Voluntary Action Indicated (VAI)No citations listed
Mar 8, 2019Voluntary Action Indicated (VAI)No citations listed
Jun 27, 2017No Action Indicated (NAI)No citations listed
Mar 4, 2016No Action Indicated (NAI)No citations listed
Apr 3, 2014Voluntary Action Indicated (VAI)No citations listed
Jun 15, 2012Voluntary Action Indicated (VAI)No citations listed
Jun 30, 2011Voluntary Action Indicated (VAI)No citations listed

Recalls

Newest first. Recalls FDA's Enforcement Report lists with this FEI as the recalling firm. The recalling firm is not always the site that made the product. Search FDA's Enforcement Report by recall number.

DateClassRecallProduct and reason
Sep 27, 2017Class IID-0212-2018FOR EXPORT ONLY Atorvastatin calcium Film-Coated Tablets a) 80 mg SMT Tabs Bulk, b) 40 mg…
Microbial Contamination of Non-Sterile Products

Facility details

Company
Pfizer Manufacturing Deutschland GmbH
Location
Freiburg im Breisgau, BW (DE)
Registration Expires
Dec 31, 2026
Operations
ANALYSIS; LABEL; MANUFACTURE; PACK
Source
decrs

Import refusals

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.