Apicore US LLC FDA Record
Apicore US LLC has 0 FDA recalls, 8 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Apicore US LLC" is on file.
- Latest inspection
- Apr 2, 2025 · NAI
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 | 1 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 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 |
|---|---|---|---|---|
| Apr 2, 2025 | East Windsor, NJ | Drugs | No Action Indicated (NAI) | 3004864046 |
| Dec 9, 2019 | East Windsor, NJ | Drugs | No Action Indicated (NAI) | 3004864046 |
| Oct 10, 2017 | East Windsor, NJ | Drugs | No Action Indicated (NAI) | 3004864046 |
| Jul 18, 2016 | East Windsor, NJ | Drugs | Voluntary Action Indicated (VAI) | 3004864046 |
| May 17, 2013 | East Windsor, NJ | Drugs | Voluntary Action Indicated (VAI) | 3004864046 |
| Sep 20, 2011 | East Windsor, NJ | Drugs | Voluntary Action Indicated (VAI) | 3004864046 |
| Jul 14, 2010 | East Windsor, NJ | Drugs | No Action Indicated (NAI) | 3004864046 |
| Dec 15, 2008 | East Windsor, NJ | Drugs | Voluntary Action Indicated (VAI) | 3004864046 |
- 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 3004864046 | East Windsor, NJ | 8 | Apr 2, 2025 |
Apicore US LLC and the FDA: common questions
Has Apicore US LLC received an FDA warning letter?
No FDA warning letter addressed to the name "Apicore US LLC" 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 Apicore US LLC received an FDA Form 483?
FDA has not published a Form 483 for "Apicore US LLC" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Apicore US LLC?
The most recent FDA inspection on file ended Apr 2, 2025 at East Windsor, NJ and was classified NAI. FDA has 8 inspections of Apicore US LLC on file.
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