Phoenix Innovative Healthcare Manufacturers Private Limited FDA Record
- Latest inspection OAI · Sep 27, 2024
- No warning letters matched by name
Phoenix Innovative Healthcare Manufacturers Private Limited has 0 FDA recalls, 4 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Phoenix Innovative Healthcare Manufacturers Private Limited" is on file.
- Latest inspection
- Sep 27, 2024 · OAI
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 | 4 | 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
Phoenix Innovative Healthcare Manufacturers Private Limited: 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 | 1 | 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 |
|---|---|---|---|---|
| Sep 27, 2024 | Navi Mumbai, India | Drugs | Official Action Indicated (OAI) | 3010408344 |
| Aug 22, 2024 | Navi Mumbai, India | Devices | No Action Indicated (NAI) | 3010408344 |
| Sep 27, 2019 | Navi Mumbai, India | Drugs | No Action Indicated (NAI) | 3010408344 |
| Oct 21, 2016 | Navi Mumbai, India | Drugs | Voluntary Action Indicated (VAI) | 3010408344 |
- 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 3010408344 | Navi Mumbai, India | 4 | Sep 27, 2024 |
Phoenix Innovative Healthcare Manufacturers Private Limited and the FDA: common questions
Has Phoenix Innovative Healthcare Manufacturers Private Limited received an FDA warning letter?
No FDA warning letter addressed to the name "Phoenix Innovative Healthcare Manufacturers 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 Phoenix Innovative Healthcare Manufacturers Private Limited received an FDA Form 483?
FDA has not published a Form 483 for "Phoenix Innovative Healthcare Manufacturers Private Limited" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Phoenix Innovative Healthcare Manufacturers Private Limited?
The most recent FDA inspection on file ended Sep 27, 2024 at Navi Mumbai, India and was classified OAI. FDA has 4 inspections of Phoenix Innovative Healthcare Manufacturers Private Limited on file, 1 of them classified OAI (official action indicated).
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