Malladi Drugs And Pharmaceuticals Ltd. FDA Record
Malladi Drugs And Pharmaceuticals Ltd. has 0 FDA recalls, 12 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Malladi Drugs And Pharmaceuticals Ltd., the most recent on Mar 9, 2018.
- Latest inspection
- Jul 3, 2026 · NAI
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 | 12 | 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
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 1 | 0 | 0 | 0 | 0 |
| 2025 | 1 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 1 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 1 | 0 | 0 | 0 | 0 |
| 2019 | 1 | 0 | 0 | 0 | 0 |
| 2018 | 1 | 0 | 1 | 0 | 0 |
| 2017 | 2 | 1 | 0 | 0 | 0 |
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Malladi Drugs And Pharmaceuticals Ltd. FDA Warning Letters
| Issued | Subject | Issuing office | Close-out letter |
|---|---|---|---|
| Mar 9, 2018 · Record page |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jul 3, 2026 | Gajulamandyam, India | Drugs | No Action Indicated (NAI) | 3004896422 |
| May 2, 2025 | Ranipet, Vellore, India | Drugs | Voluntary Action Indicated (VAI) | 3002780785 |
| Nov 11, 2022 | Vellore, India | Drugs | Voluntary Action Indicated (VAI) | 3005115135 |
| Jan 31, 2020 | Gajulamandyam, India | Drugs | Voluntary Action Indicated (VAI) | 3004896422 |
| Aug 2, 2019 | Ranipet, Vellore, India | Drugs | No Action Indicated (NAI) | 3002780785 |
| Oct 9, 2018 | Gajulamandyam, India | Drugs | Voluntary Action Indicated (VAI) | 3004896422 |
| Sep 8, 2017 | Vellore, India | Drugs | Official Action Indicated (OAI) | 3005115135 |
| Aug 4, 2017 | Gajulamandyam, India | Drugs | Voluntary Action Indicated (VAI) | 3004896422 |
| Nov 18, 2016 | Ranipet, Vellore, India | Drugs | Voluntary Action Indicated (VAI) | 3002780785 |
| Dec 19, 2014 | Gajulamandyam, India | Drugs | Voluntary Action Indicated (VAI) | 3004896422 |
| Sep 14, 2012 | Ranipet, Vellore, India | Drugs | Voluntary Action Indicated (VAI) | 3002780785 |
| Apr 3, 2009 | Ranipet, Vellore, India | Drugs | No Action Indicated (NAI) | 3002780785 |
- 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 Malladi Drugs And Pharmaceuticals Ltd.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3004896422 | Gajulamandyam, India | 5 | Jul 3, 2026 |
| FEI 3002780785 | Ranipet, Vellore, India | 5 | May 2, 2025 |
| FEI 3005115135 | Vellore, India | 2 | Nov 11, 2022 |
Malladi Drugs And Pharmaceuticals Ltd. and the FDA: common questions
Has Malladi Drugs And Pharmaceuticals Ltd. received an FDA warning letter?
Yes. FDA has issued 1 warning letter to Malladi Drugs And Pharmaceuticals Ltd.. The most recent is dated Mar 9, 2018.
Has Malladi Drugs And Pharmaceuticals Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "Malladi Drugs And Pharmaceuticals Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Malladi Drugs And Pharmaceuticals Ltd.?
The most recent FDA inspection on file ended Jul 3, 2026 at Gajulamandyam, India and was classified NAI. FDA has 12 inspections of Malladi Drugs And Pharmaceuticals Ltd. on file, 1 of them classified OAI (official action indicated).
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