Sharon Bio-Medicine Ltd FDA Record
Sharon Bio-Medicine Ltd has 0 FDA recalls, 4 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Sharon Bio-Medicine Ltd, the most recent on Jun 22, 2015.
- Latest inspection
- Apr 18, 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 | 4 | 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 | 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 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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Sharon Bio-Medicine Ltd FDA Warning Letters
| Issued | Subject | Issuing office | Close-out letter |
|---|---|---|---|
| Jun 22, 2015 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Apr 18, 2025 | Raigad District, India | Veterinary | Voluntary Action Indicated (VAI) | 3004455093 |
| Feb 22, 2019 | Raigad District, India | Drugs | Voluntary Action Indicated (VAI) | 3004455093 |
| Aug 13, 2015 | Dehradun, India | Drugs | Voluntary Action Indicated (VAI) | 3005925733 |
| Jul 7, 2015 | Raigad District, India | Drugs | Voluntary Action Indicated (VAI) | 3004455093 |
- 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 Sharon Bio-Medicine Ltd: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3004455093 | Raigad District, India | 3 | Apr 18, 2025 |
| FEI 3005925733 | Dehradun, India | 1 | Aug 13, 2015 |
Sharon Bio-Medicine Ltd and the FDA: common questions
Has Sharon Bio-Medicine Ltd received an FDA warning letter?
Yes. FDA has issued 1 warning letter to Sharon Bio-Medicine Ltd. The most recent is dated Jun 22, 2015.
Has Sharon Bio-Medicine Ltd received an FDA Form 483?
FDA has not published a Form 483 for "Sharon Bio-Medicine Ltd" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Sharon Bio-Medicine Ltd?
The most recent FDA inspection on file ended Apr 18, 2025 at Raigad District, India and was classified VAI. FDA has 4 inspections of Sharon Bio-Medicine Ltd on file.
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