Bakul Aromatics And Chemicals Private Limited FDA Record
Bakul Aromatics And Chemicals Private Limited has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Bakul Aromatics And Chemicals Private Limited" is on file.
- Latest inspection
- Jun 14, 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 | 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 | 1 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 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 |
|---|---|---|---|---|
| Jun 14, 2025 | Raigad, India | Drugs | Voluntary Action Indicated (VAI) | 3010437486 |
| Feb 7, 2020 | Raigad, India | Drugs | Voluntary Action Indicated (VAI) | 3010437486 |
- 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 3010437486 | Raigad, India | 2 | Jun 14, 2025 |
Bakul Aromatics And Chemicals Private Limited and the FDA: common questions
Has Bakul Aromatics And Chemicals Private Limited received an FDA warning letter?
No FDA warning letter addressed to the name "Bakul Aromatics And Chemicals 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 Bakul Aromatics And Chemicals Private Limited received an FDA Form 483?
FDA has not published a Form 483 for "Bakul Aromatics And Chemicals Private Limited" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Bakul Aromatics And Chemicals Private Limited?
The most recent FDA inspection on file ended Jun 14, 2025 at Raigad, India and was classified VAI. FDA has 2 inspections of Bakul Aromatics And Chemicals Private Limited on file.
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