Amol Pharmaceuticals Private Ltd. FDA Record
Amol Pharmaceuticals Private Ltd. has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Amol Pharmaceuticals Private Ltd." 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 | 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 28, 2025 | Sitapura Industrial Area, India | Drugs | Voluntary Action Indicated (VAI) | 3003925108 |
| Sep 13, 2019 | Sitapura Industrial Area, India | Drugs | Voluntary Action Indicated (VAI) | 3003925108 |
| Feb 16, 2018 | Sitapura Industrial Area, India | Drugs | Voluntary Action Indicated (VAI) | 3003925108 |
| Dec 5, 2017 | Sitapura Industrial Area, India | Food/Cosmetics | No Action Indicated (NAI) | 3003925108 |
| May 15, 2012 | Sitapura Industrial Area, India | Food/Cosmetics | Voluntary Action Indicated (VAI) | 3003925108 |
- 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 3003925108 | Sitapura Industrial Area, India | 5 | Mar 28, 2025 |
Amol Pharmaceuticals Private Ltd. and the FDA: common questions
Has Amol Pharmaceuticals Private Ltd. received an FDA warning letter?
No FDA warning letter addressed to the name "Amol Pharmaceuticals Private Ltd." 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 Amol Pharmaceuticals Private Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "Amol Pharmaceuticals Private Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Amol Pharmaceuticals Private Ltd.?
The most recent FDA inspection on file ended Mar 28, 2025 at Sitapura Industrial Area, India and was classified VAI. FDA has 5 inspections of Amol Pharmaceuticals Private Ltd. on file.
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