R.L. Fine Chem Private Limited FDA Record
R.L. Fine Chem Private Limited has 0 FDA recalls, 6 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "R.L. Fine Chem Private Limited" is on file.
- Latest inspection
- Aug 28, 2026 · 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 | 6 | 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 | 1 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 1 | 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 |
|---|---|---|---|---|
| Aug 28, 2026 | Bengaluru, India | Drugs | Voluntary Action Indicated (VAI) | 3013140488 |
| Apr 14, 2023 | Bengaluru, India | Drugs | Voluntary Action Indicated (VAI) | 3013140488 |
| Feb 22, 2019 | Bengaluru, India | Drugs | Voluntary Action Indicated (VAI) | 3005560263 |
| Jul 17, 2015 | Bengaluru, India | Drugs | Voluntary Action Indicated (VAI) | 3005560263 |
| Jul 19, 2013 | Bengaluru, India | Drugs | Voluntary Action Indicated (VAI) | 3005560263 |
| Mar 24, 2011 | Bengaluru, India | Drugs | Voluntary Action Indicated (VAI) | 3005560263 |
- 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 3013140488 | Bengaluru, India | 2 | Aug 28, 2026 |
| FEI 3005560263 | Bengaluru, India | 4 | Feb 22, 2019 |
R.L. Fine Chem Private Limited and the FDA: common questions
Has R.L. Fine Chem Private Limited received an FDA warning letter?
No FDA warning letter addressed to the name "R.L. Fine Chem 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 R.L. Fine Chem Private Limited received an FDA Form 483?
FDA has not published a Form 483 for "R.L. Fine Chem Private Limited" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect R.L. Fine Chem Private Limited?
The most recent FDA inspection on file ended Aug 28, 2026 at Bengaluru, India and was classified VAI. FDA has 6 inspections of R.L. Fine Chem Private Limited on file.
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