Merz Pharma GmbH & Co., KGaA FDA Record
Merz Pharma GmbH & Co., KGaA has 0 FDA recalls, 8 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Merz Pharma GmbH & Co., KGaA" is on file.
- Latest inspection
- Nov 6, 2024 · VAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | 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 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 1 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 1 | 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 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Nov 6, 2024 | Reinheim, Germany | Drugs | Voluntary Action Indicated (VAI) | 3006999111 |
| Jun 29, 2022 | Dessau-Rosslau, Germany | Drugs | Voluntary Action Indicated (VAI) | 3006896175 |
| Aug 23, 2019 | Reinheim, Germany | Drugs | Voluntary Action Indicated (VAI) | 3006999111 |
| Jul 4, 2017 | Dessau-Rosslau, Germany | Drugs | No Action Indicated (NAI) | 3006896175 |
| Apr 29, 2016 | Reinheim, Germany | Drugs | No Action Indicated (NAI) | 3006999111 |
| Sep 15, 2015 | Dessau-Rosslau, Germany | Drugs | No Action Indicated (NAI) | 3006896175 |
| Sep 25, 2013 | Dessau-Rosslau, Germany | Drugs | No Action Indicated (NAI) | 3006896175 |
| Oct 28, 2011 | Dessau-Rosslau, Germany | Drugs | No Action Indicated (NAI) | 3006896175 |
- 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 3006999111 | Reinheim, Germany | 3 | Nov 6, 2024 |
| FEI 3006896175 | Dessau-Rosslau, Germany | 5 | Jun 29, 2022 |
Merz Pharma GmbH & Co., KGaA and the FDA: common questions
Has Merz Pharma GmbH & Co., KGaA received an FDA warning letter?
No FDA warning letter addressed to the name "Merz Pharma GmbH & Co., KGaA" 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 Merz Pharma GmbH & Co., KGaA received an FDA Form 483?
FDA has not published a Form 483 for "Merz Pharma GmbH & Co., KGaA" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Merz Pharma GmbH & Co., KGaA?
The most recent FDA inspection on file ended Nov 6, 2024 at Reinheim, Germany and was classified VAI. FDA has 8 inspections of Merz Pharma GmbH & Co., KGaA on file.
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