Haupt Pharma Wuelfing GmbH FDA Record
Haupt Pharma Wuelfing GmbH has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Haupt Pharma Wuelfing GmbH" is on file.
- Latest inspection
- Jun 6, 2023 · 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 | 7 | 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 | 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 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 1 | 0 | 0 | 0 | 0 |
| 2017 | 1 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jun 6, 2023 | Gronau (Leine), Germany | Drugs | Voluntary Action Indicated (VAI) | 3003183252 |
| Dec 7, 2018 | Gronau (Leine), Germany | Veterinary | No Action Indicated (NAI) | 3003183252 |
| Mar 17, 2017 | Gronau (Leine), Germany | Drugs | No Action Indicated (NAI) | 3003183252 |
| Jun 16, 2015 | Gronau (Leine), Germany | Veterinary | Voluntary Action Indicated (VAI) | 3003183252 |
| Mar 28, 2014 | Gronau (Leine), Germany | Drugs | Voluntary Action Indicated (VAI) | 3003183252 |
| Apr 20, 2012 | Gronau (Leine), Germany | Drugs | Voluntary Action Indicated (VAI) | 3003183252 |
| Nov 6, 2008 | Gronau (Leine), Germany | Drugs | Voluntary Action Indicated (VAI) | 3003183252 |
- 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 3003183252 | Gronau (Leine), Germany | 7 | Jun 6, 2023 |
Haupt Pharma Wuelfing GmbH and the FDA: common questions
Has Haupt Pharma Wuelfing GmbH received an FDA warning letter?
No FDA warning letter addressed to the name "Haupt Pharma Wuelfing 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 Haupt Pharma Wuelfing GmbH received an FDA Form 483?
FDA has not published a Form 483 for "Haupt Pharma Wuelfing GmbH" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Haupt Pharma Wuelfing GmbH?
The most recent FDA inspection on file ended Jun 6, 2023 at Gronau (Leine), Germany and was classified VAI. FDA has 7 inspections of Haupt Pharma Wuelfing GmbH on file.
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