Covalent Laboratories Private Limited FDA Record
Covalent Laboratories Private Limited has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Covalent Laboratories Private Limited" is on file.
- Latest inspection
- Apr 25, 2025 · NAI
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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 | 3 | 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 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 1 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Apr 25, 2025 | Sangareddy, India | Drugs | No Action Indicated (NAI) | 3004590215 |
| Nov 23, 2018 | Sangareddy, India | Drugs | No Action Indicated (NAI) | 3004590215 |
| Apr 10, 2015 | Sangareddy, India | Drugs | No Action Indicated (NAI) | 3004590215 |
- 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 3004590215 | Sangareddy, India | 3 | Apr 25, 2025 |
Covalent Laboratories Private Limited and the FDA: common questions
Has Covalent Laboratories Private Limited received an FDA warning letter?
No FDA warning letter addressed to the name "Covalent Laboratories Private 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 Covalent Laboratories Private Limited received an FDA Form 483?
FDA has not published a Form 483 for "Covalent Laboratories Private Limited" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Covalent Laboratories Private Limited?
The most recent FDA inspection on file ended Apr 25, 2025 at Sangareddy, India and was classified NAI. FDA has 3 inspections of Covalent Laboratories Private Limited on file.
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