Avantor Performance Materials Inc
FDA Regulatory Profile
Avantor Performance Materials Inc has 3 FDA recalls, 15 inspections, 0 510(k) clearances and 0 compliance actions on record.
- Latest recall
- D-0488-2026 · Class III · Mar 31, 2026
- Latest inspection
- May 27, 2025 · VAI
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 3 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 15 | Nov 11, 2026 | Newest record Nov 5, 2026 | Current |
|---|
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0488-2026 | Class III | Magnesium Chloride, 6-Hydrate, Crystal, 500G per bottle, Bulk active pharmaceutical ingredient… | Mar 31, 2026 |
| D-0575-2020 | Class II | Potassium Phosphate, Monobasic, Crystal, NF, Multi-Compendial, Bulk Pharmaceutical Chemical… | Oct 30, 2019 |
| D-0563-2016 | Class III | Magnesium Sulfate 7-Hydrate, (For Parenteral Use) USP -GenAR, 100LB, Avantor Performance Materials… | Oct 30, 2015 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| May 27, 2025 | Phillipsburg, NJ | Drugs | Voluntary Action Indicated (VAI) | 2220077 |
| Nov 13, 2024 | Paris, KY | Veterinary | Voluntary Action Indicated (VAI) | 1045125 |
| Apr 14, 2021 | Paris, KY | Veterinary | Voluntary Action Indicated (VAI) | 1045125 |
| Aug 12, 2019 | Phillipsburg, NJ | Drugs | No Action Indicated (NAI) | 2220077 |
| Aug 3, 2018 | Phillipsburg, NJ | Drugs | No Action Indicated (NAI) | 2220077 |
| Aug 29, 2017 | Phillipsburg, NJ | Food/Cosmetics | No Action Indicated (NAI) | 2220077 |
| Oct 24, 2016 | Paris, KY | Drugs | Voluntary Action Indicated (VAI) | 1045125 |
| Jul 17, 2015 | Paris, KY | Drugs | Voluntary Action Indicated (VAI) | 1045125 |
| Nov 15, 2013 | Phillipsburg, NJ | Drugs | No Action Indicated (NAI) | 2220077 |
| Aug 17, 2012 | Paris, KY | Drugs | Voluntary Action Indicated (VAI) | 1045125 |
| May 11, 2012 | Phillipsburg, NJ | Drugs | No Action Indicated (NAI) | 2220077 |
| Jan 11, 2011 | Phillipsburg, NJ | Drugs | No Action Indicated (NAI) | 2220077 |
| Dec 10, 2010 | Paris, KY | Drugs | No Action Indicated (NAI) | 1045125 |
| Jul 2, 2009 | Phillipsburg, NJ | Drugs | No Action Indicated (NAI) | 2220077 |
| Apr 15, 2009 | Paris, KY | Drugs | No Action Indicated (NAI) | 1045125 |
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.