Catalent France Beinheim SA FDA Record
Catalent France Beinheim SA has 0 FDA recalls, 6 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Catalent France Beinheim SA" is on file.
- Latest inspection
- Nov 25, 2022 · 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 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 1 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 1 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 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 25, 2022 | Beinheim, France | Drugs | Voluntary Action Indicated (VAI) | 3002808036 |
| Oct 29, 2020 | Beinheim, France | Drugs | Voluntary Action Indicated (VAI) | 3002808036 |
| Jul 21, 2017 | Beinheim, France | Drugs | Voluntary Action Indicated (VAI) | 3002808036 |
| Mar 20, 2014 | Beinheim, France | Drugs | No Action Indicated (NAI) | 3002808036 |
| Jul 13, 2012 | Beinheim, France | Drugs | No Action Indicated (NAI) | 3002808036 |
| Sep 17, 2009 | Beinheim, France | Drugs | Voluntary Action Indicated (VAI) | 3002808036 |
- 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 3002808036 | Beinheim, France | 6 | Nov 25, 2022 |
Catalent France Beinheim SA and the FDA: common questions
Has Catalent France Beinheim SA received an FDA warning letter?
No FDA warning letter addressed to the name "Catalent France Beinheim SA" 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 Catalent France Beinheim SA received an FDA Form 483?
FDA has not published a Form 483 for "Catalent France Beinheim SA" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Catalent France Beinheim SA?
The most recent FDA inspection on file ended Nov 25, 2022 at Beinheim, France and was classified VAI. FDA has 6 inspections of Catalent France Beinheim SA on file.
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