Novartis Pharma Produktions GmbH FDA Record
Novartis Pharma Produktions GmbH has 0 FDA recalls, 6 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Novartis Pharma Produktions GmbH" is on file.
- Latest inspection
- Jul 11, 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 | 6 | 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 | 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 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jul 11, 2024 | Wehr, Germany | Drugs | Voluntary Action Indicated (VAI) | 3000978864 |
| Sep 27, 2019 | Wehr, Germany | Drugs | No Action Indicated (NAI) | 3000978864 |
| May 19, 2017 | Wehr, Germany | Drugs | No Action Indicated (NAI) | 3000978864 |
| Jun 18, 2015 | Wehr, Germany | Drugs | No Action Indicated (NAI) | 3000978864 |
| Jun 24, 2013 | Wehr, Germany | Drugs | No Action Indicated (NAI) | 3000978864 |
| Sep 15, 2011 | Wehr, Germany | Drugs | Voluntary Action Indicated (VAI) | 3000978864 |
- 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 3000978864 | Wehr, Germany | 6 | Jul 11, 2024 |
Novartis Pharma Produktions GmbH and the FDA: common questions
Has Novartis Pharma Produktions GmbH received an FDA warning letter?
No FDA warning letter addressed to the name "Novartis Pharma Produktions 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 Novartis Pharma Produktions GmbH received an FDA Form 483?
FDA has not published a Form 483 for "Novartis Pharma Produktions GmbH" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Novartis Pharma Produktions GmbH?
The most recent FDA inspection on file ended Jul 11, 2024 at Wehr, Germany and was classified VAI. FDA has 6 inspections of Novartis Pharma Produktions GmbH on file.
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