Cosmetic Essence, Inc. FDA Record
Cosmetic Essence, Inc. has 0 FDA recalls, 11 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Cosmetic Essence, Inc." is on file.
- Latest inspection
- Mar 28, 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 | 11 | 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 | 1 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 1 | 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 |
|---|---|---|---|---|
| Mar 28, 2025 | Roanoke, VA | Drugs | Voluntary Action Indicated (VAI) | 1117550 |
| Dec 6, 2024 | Ridgefield, NJ | Drugs | Voluntary Action Indicated (VAI) | 1000222321 |
| Feb 28, 2020 | Roanoke, VA | Drugs | Voluntary Action Indicated (VAI) | 1117550 |
| Apr 13, 2018 | Ridgefield, NJ | Drugs | No Action Indicated (NAI) | 1000222321 |
| Feb 13, 2017 | Holmdel, NJ | Food/Cosmetics | Voluntary Action Indicated (VAI) | 3002633015 |
| Jun 19, 2015 | Roanoke, VA | Drugs | Voluntary Action Indicated (VAI) | 1117550 |
| Apr 17, 2014 | Holmdel, NJ | Food/Cosmetics | No Action Indicated (NAI) | 3002633015 |
| Mar 20, 2014 | Ridgefield, NJ | Drugs | Voluntary Action Indicated (VAI) | 1000222321 |
| Dec 15, 2011 | Ridgefield, NJ | Drugs | No Action Indicated (NAI) | 1000222321 |
| Sep 19, 2011 | Roanoke, VA | Food/Cosmetics | Voluntary Action Indicated (VAI) | 1117550 |
| Dec 23, 2008 | Holmdel, NJ | Drugs | Voluntary Action Indicated (VAI) | 3002633015 |
- 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 1117550 | Roanoke, VA | 4 | Mar 28, 2025 |
| FEI 1000222321 | Ridgefield, NJ | 4 | Dec 6, 2024 |
| FEI 3002633015 | Holmdel, NJ | 3 | Feb 13, 2017 |
Cosmetic Essence, Inc. and the FDA: common questions
Has Cosmetic Essence, Inc. received an FDA warning letter?
No FDA warning letter addressed to the name "Cosmetic Essence, Inc." 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 Cosmetic Essence, Inc. received an FDA Form 483?
FDA has not published a Form 483 for "Cosmetic Essence, Inc." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Cosmetic Essence, Inc.?
The most recent FDA inspection on file ended Mar 28, 2025 at Roanoke, VA and was classified VAI. FDA has 11 inspections of Cosmetic Essence, Inc. on file.
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