Amoli Organics (A Division Of Umedica Laboratories Pvt Ltd) FDA Record
- Latest inspection VAI · Mar 4, 2024
- No warning letters matched by name
Amoli Organics (A Division Of Umedica Laboratories Pvt Ltd) has 0 FDA recalls, 8 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Amoli Organics (A Division Of Umedica Laboratories Pvt Ltd)" is on file.
- Latest inspection
- Mar 4, 2024 · VAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 11, 2026 (checked Nov 15, 2026, unchanged) | File dated Nov 10, 2026 | Current |
| 510(k) clearances | 0 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 8 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
Amoli Organics (A Division Of Umedica Laboratories Pvt Ltd): FDA inspections per year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 2 | 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 | 1 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Mar 4, 2024 | Vapi, India | Drugs | Voluntary Action Indicated (VAI) | 3004810446 |
| Jan 12, 2024 | Padra, India | Drugs | Voluntary Action Indicated (VAI) | 3007836955 |
| Jul 20, 2018 | Vapi, India | Drugs | No Action Indicated (NAI) | 3004810446 |
| Mar 31, 2017 | Vapi, India | Drugs | Voluntary Action Indicated (VAI) | 3004810446 |
| Aug 20, 2016 | Padra, India | Drugs | No Action Indicated (NAI) | 3007836955 |
| Feb 12, 2016 | Vapi, India | Drugs | Voluntary Action Indicated (VAI) | 3004810446 |
| Apr 24, 2014 | Vapi, India | Drugs | Voluntary Action Indicated (VAI) | 3004810446 |
| Sep 30, 2010 | Vapi, India | Drugs | Voluntary Action Indicated (VAI) | 3004810446 |
- 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 3004810446 | Vapi, India | 6 | Mar 4, 2024 |
| FEI 3007836955 | Padra, India | 2 | Jan 12, 2024 |
Amoli Organics (A Division Of Umedica Laboratories Pvt Ltd) and the FDA: common questions
Has Amoli Organics (A Division Of Umedica Laboratories Pvt Ltd) received an FDA warning letter?
No FDA warning letter addressed to the name "Amoli Organics (A Division Of Umedica Laboratories Pvt Ltd)" 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 Amoli Organics (A Division Of Umedica Laboratories Pvt Ltd) received an FDA Form 483?
FDA has not published a Form 483 for "Amoli Organics (A Division Of Umedica Laboratories Pvt Ltd)" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Amoli Organics (A Division Of Umedica Laboratories Pvt Ltd)?
The most recent FDA inspection on file ended Mar 4, 2024 at Vapi, India and was classified VAI. FDA has 8 inspections of Amoli Organics (A Division Of Umedica Laboratories Pvt Ltd) on file.
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