Shilpa Pharma Lifesciences Limited FDA Record
Shilpa Pharma Lifesciences Limited has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Shilpa Pharma Lifesciences Limited" is on file.
- Latest inspection
- Mar 14, 2025 · 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 | 7 | 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 | 2 | 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 | 1 | 0 | 0 | 0 | 0 |
| 2019 | 1 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Mar 14, 2025 | Chicksugur, Raichur, India | Drugs | No Action Indicated (NAI) | 3007197995 |
| Mar 7, 2025 | Deosugur, India | Drugs | Voluntary Action Indicated (VAI) | 3025560903 |
| Feb 7, 2020 | Chicksugur, Raichur, India | Drugs | No Action Indicated (NAI) | 3007197995 |
| Jul 26, 2019 | Chicksugur, Raichur, India | Drugs | Voluntary Action Indicated (VAI) | 3007197995 |
| Dec 16, 2016 | Chicksugur, Raichur, India | Drugs | Voluntary Action Indicated (VAI) | 3007197995 |
| Mar 9, 2015 | Chicksugur, Raichur, India | Drugs | Voluntary Action Indicated (VAI) | 3007197995 |
| May 3, 2013 | Chicksugur, Raichur, India | Drugs | Official Action Indicated (OAI) | 3007197995 |
- 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 3007197995 | Chicksugur, Raichur, India | 6 | Mar 14, 2025 |
| FEI 3025560903 | Deosugur, India | 1 | Mar 7, 2025 |
Shilpa Pharma Lifesciences Limited and the FDA: common questions
Has Shilpa Pharma Lifesciences Limited received an FDA warning letter?
No FDA warning letter addressed to the name "Shilpa Pharma Lifesciences Limited" 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 Shilpa Pharma Lifesciences Limited received an FDA Form 483?
FDA has not published a Form 483 for "Shilpa Pharma Lifesciences Limited" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Shilpa Pharma Lifesciences Limited?
The most recent FDA inspection on file ended Mar 14, 2025 at Chicksugur, Raichur, India and was classified NAI. FDA has 7 inspections of Shilpa Pharma Lifesciences Limited on file, 1 of them classified OAI (official action indicated).
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