Kopran Research Laboratories Limited FDA Record
Kopran Research Laboratories Limited has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Kopran Research Laboratories Limited" is on file.
- Latest inspection
- Apr 25, 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 | 2 | 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 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Apr 25, 2025 | Mahad, India | Drugs | No Action Indicated (NAI) | 3004081315 |
| Jan 25, 2019 | Mahad, India | Drugs | No Action Indicated (NAI) | 3004081315 |
- 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 3004081315 | Mahad, India | 2 | Apr 25, 2025 |
Kopran Research Laboratories Limited and the FDA: common questions
Has Kopran Research Laboratories Limited received an FDA warning letter?
No FDA warning letter addressed to the name "Kopran Research Laboratories 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 Kopran Research Laboratories Limited received an FDA Form 483?
FDA has not published a Form 483 for "Kopran Research Laboratories Limited" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Kopran Research Laboratories Limited?
The most recent FDA inspection on file ended Apr 25, 2025 at Mahad, India and was classified NAI. FDA has 2 inspections of Kopran Research Laboratories Limited on file.
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