Pfizer Manufacturing Deutschland GmbH FDA Record
Pfizer Manufacturing Deutschland GmbH has 1 FDA recall, 8 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Pfizer Manufacturing Deutschland GmbH" is on file.
- Latest recall
- D-0052-2027 · Sep 29, 2026 · filed under Pfizer
- Latest recall under this name
- D-0212-2018 · Class II · Sep 27, 2017
- Latest inspection
- Jul 2, 2025 · VAI
Newer recall under related name Pfizer: Sep 29, 2026, D-0052-2027.
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 1 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 8 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 1 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 1 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 1 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 1 | 0 | 0 | 1 | 0 |
Recent recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0212-2018 | Class II | FOR EXPORT ONLY Atorvastatin calcium Film-Coated Tablets a) 80 mg SMT Tabs Bulk, b) 40 mg SMT G EP… | Sep 27, 2017 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jul 2, 2025 | Freiburg Im Breisgau, Germany | Drugs | Voluntary Action Indicated (VAI) | 3002807097 |
| May 11, 2023 | Freiburg Im Breisgau, Germany | Drugs | Voluntary Action Indicated (VAI) | 3002807097 |
| Mar 8, 2019 | Freiburg Im Breisgau, Germany | Drugs | Voluntary Action Indicated (VAI) | 3002807097 |
| Jun 27, 2017 | Freiburg Im Breisgau, Germany | Drugs | No Action Indicated (NAI) | 3002807097 |
| Mar 4, 2016 | Freiburg Im Breisgau, Germany | Drugs | No Action Indicated (NAI) | 3002807097 |
| Apr 3, 2014 | Freiburg Im Breisgau, Germany | Drugs | Voluntary Action Indicated (VAI) | 3002807097 |
| Jun 15, 2012 | Freiburg Im Breisgau, Germany | Drugs | Voluntary Action Indicated (VAI) | 3002807097 |
| Jun 30, 2011 | Freiburg Im Breisgau, Germany | Drugs | Voluntary Action Indicated (VAI) | 3002807097 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3002807097 | Freiburg Im Breisgau, Germany | 8 | Jul 2, 2025 |
Pfizer Manufacturing Deutschland GmbH and the FDA: common questions
Has Pfizer Manufacturing Deutschland GmbH received an FDA warning letter?
No FDA warning letter addressed to the name "Pfizer Manufacturing Deutschland GmbH" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Pfizer Manufacturing Deutschland GmbH received an FDA Form 483?
FDA has not published a Form 483 for "Pfizer Manufacturing Deutschland GmbH" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Pfizer Manufacturing Deutschland GmbH?
The most recent FDA inspection on file ended Jul 2, 2025 at Freiburg Im Breisgau, Germany and was classified VAI. FDA has 8 inspections of Pfizer Manufacturing Deutschland GmbH on file.
Has Pfizer Manufacturing Deutschland GmbH had an FDA recall?
Yes. Pfizer Manufacturing Deutschland GmbH has 1 FDA recall on record. The most recent under this name started Sep 27, 2017. A newer recall, dated Sep 29, 2026, is filed under the related name Pfizer.
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