DuPont Nutrition USA, Inc FDA Record
- Latest inspection VAI · Oct 25, 2023
- 1 Class I recall
- Last warning letter 2022
DuPont Nutrition USA, Inc has 10 FDA recalls (1 Class I), 8 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to DuPont Nutrition USA, Inc, the most recent on Dec 2, 2022.
- Latest recall
- D-0545-2023 · Class III · Apr 13, 2023
- Latest inspection
- Oct 25, 2023 · VAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 10 (1 Class I) | 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 | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
DuPont Nutrition USA, Inc: FDA inspections per 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 | 1 | 0 | 0 | 8 | 0 |
| 2022 | 1 | 0 | 1 | 0 | 0 |
| 2021 | 2 | 1 | 0 | 2 | 1 |
| 2020 | 0 | 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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DuPont Nutrition USA, Inc FDA Warning Letters
| Issued | Subject | Issuing office | Close-out letter |
|---|---|---|---|
| Dec 2, 2022 · Letter on fda.gov | CGMP/Drug Products/Adulterated | Division of Pharmaceutical Quality Operations I |
Recent recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0545-2023 | Class III | Avicel PH-102 NF, Microcrystalline Cellulose NF, Net Content/Gross Weight 20.0 KG / 21.1 KG bulk… | Apr 13, 2023 |
| D-0544-2023 | Class III | Avicel PH-101 NF, Microcrystalline Cellulose NF, Net Content/Gross Weight 50.0 KG / 54.5 KG bulk… | Apr 13, 2023 |
| D-0546-2023 | Class III | Avicel PH-200 NF, Microcrystalline Cellulose NF, Net Content/Gross Weight 20.0 KG / 21.1 KG bulk… | Apr 13, 2023 |
| D-0547-2023 | Class III | Avicel DG, MCC/Dibasic Calcium Phosphate, Net Content/Gross Weight 20.0 KG / 21.1 KG bulk container… | Apr 13, 2023 |
| D-0352-2023 | Class III | BD-102 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp., Net Content/Gross Weight 20.0 KG / 21.1 KG… | Feb 1, 2023 |
| D-0350-2023 | Class III | Avicel PH- 102 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp, Net Content/Gross Weight 20.0 KG /… | Feb 1, 2023 |
| D-0349-2023 | Class III | Avicel PH- 101 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp. Net Content/Gross Weight 50.0 KG /… | Feb 1, 2023 |
| D-0351-2023 | Class III | Avicel PH-200 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp, Net Content/Gross Weight 20.0 KG /… | Feb 1, 2023 |
| D-0830-2021 | Class I | Avicel RC-591 NF (MCC/Carboxymethylcellulose Sodium) NF, bulk powder, 80.0 KG drum, Manufactured by… | Aug 27, 2021 |
| D-0728-2021 | Class III | Avicel, Mirocrystalline cellulose, packaged in bulk as PH101 NF, PH102 NF, PH200 NF, Manufactured… | Aug 5, 2021 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Oct 25, 2023 | Newark, DE | Drugs | Voluntary Action Indicated (VAI) | 3013947845 |
| Sep 14, 2022 | Wilmington, DE | Food/Cosmetics | No Action Indicated (NAI) | 3013947174 |
| Dec 15, 2021 | Newark, DE | Drugs | Official Action Indicated (OAI) | 3013947845 |
| Aug 24, 2021 | Wilmington, DE | Veterinary | Voluntary Action Indicated (VAI) | 3013947174 |
| Apr 27, 2017 | Newark, DE | Food/Cosmetics | No Action Indicated (NAI) | 3013947845 |
| Jun 10, 2010 | Newark, DE | Drugs | No Action Indicated (NAI) | 3013947845 |
| Jun 3, 2010 | Newark, DE | Drugs | No Action Indicated (NAI) | 3013947845 |
| Feb 5, 2010 | Newark, DE | Drugs | No Action Indicated (NAI) | 3013947845 |
- 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.
Compliance Actions
FDA's compliance actions data lists 1 compliance action under DuPont Nutrition USA, Inc: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3013947845 | Newark, DE | 6 | Oct 25, 2023 |
| FEI 3013947174 | Wilmington, DE | 2 | Sep 14, 2022 |
DuPont Nutrition USA, Inc and the FDA: common questions
Has DuPont Nutrition USA, Inc received an FDA warning letter?
Yes. FDA has issued 1 warning letter to DuPont Nutrition USA, Inc. The most recent is dated Dec 2, 2022, with the subject "CGMP/Drug Products/Adulterated".
Has DuPont Nutrition USA, Inc received an FDA Form 483?
FDA has not published a Form 483 for "DuPont Nutrition USA, Inc" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect DuPont Nutrition USA, Inc?
The most recent FDA inspection on file ended Oct 25, 2023 at Newark, DE and was classified VAI. FDA has 8 inspections of DuPont Nutrition USA, Inc on file, 1 of them classified OAI (official action indicated).
Has DuPont Nutrition USA, Inc had an FDA recall?
Yes. DuPont Nutrition USA, Inc has 10 FDA recalls on record, 1 of them Class I, the most serious class. The most recent started Apr 13, 2023.
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