Aprecia Pharmaceuticals, LLC FDA Record
Aprecia Pharmaceuticals, LLC has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Aprecia Pharmaceuticals, LLC" is on file.
- Latest inspection
- Mar 21, 2025 · 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 | 5 | 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 | 1 | 0 | 0 | 0 | 0 |
| 2017 | 1 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Mar 21, 2025 | Mason, OH | Drugs | Voluntary Action Indicated (VAI) | 3012061714 |
| May 23, 2019 | Mason, OH | Drugs | No Action Indicated (NAI) | 3012061714 |
| May 23, 2018 | Mason, OH | Drugs | No Action Indicated (NAI) | 3012061714 |
| Dec 5, 2017 | East Windsor, NJ | Drugs | No Action Indicated (NAI) | 3011249366 |
| Jun 11, 2015 | East Windsor, NJ | Drugs | No Action Indicated (NAI) | 3011249366 |
- 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 3012061714 | Mason, OH | 3 | Mar 21, 2025 |
| FEI 3011249366 | East Windsor, NJ | 2 | Dec 5, 2017 |
Aprecia Pharmaceuticals, LLC and the FDA: common questions
Has Aprecia Pharmaceuticals, LLC received an FDA warning letter?
No FDA warning letter addressed to the name "Aprecia Pharmaceuticals, 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 Aprecia Pharmaceuticals, LLC received an FDA Form 483?
FDA has not published a Form 483 for "Aprecia Pharmaceuticals, LLC" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Aprecia Pharmaceuticals, LLC?
The most recent FDA inspection on file ended Mar 21, 2025 at Mason, OH and was classified VAI. FDA has 5 inspections of Aprecia Pharmaceuticals, LLC on file.
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