MP Biomedicals Asia Pacific Pte Ltd FDA Record
- Latest inspection VAI · Mar 21, 2025
- No warning letters matched by name
MP Biomedicals Asia Pacific Pte Ltd has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "MP Biomedicals Asia Pacific Pte Ltd" is on file. FDA has published 1 Form 483 for MP Biomedicals Asia Pacific Pte Ltd.
- Latest inspection
- Mar 21, 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 | 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
MP Biomedicals Asia Pacific Pte Ltd: FDA inspections per 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 |
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MP Biomedicals Asia Pacific Pte Ltd Form 483s
| Date | Document | FEI |
|---|---|---|
| Mar 21, 2025 · Document on fda.gov | 483 | 3008819649 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Mar 21, 2025 | Singapore, Singapore | Biologics | Voluntary Action Indicated (VAI) | 3008819649 |
| Dec 14, 2018 | Singapore, Singapore | Biologics | Voluntary Action Indicated (VAI) | 3008819649 |
| Nov 7, 2016 | Singapore, Singapore | Biologics | Voluntary Action Indicated (VAI) | 3008819649 |
- 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 3008819649 | Singapore, Singapore | 3 | Mar 21, 2025 |
MP Biomedicals Asia Pacific Pte Ltd and the FDA: common questions
Has MP Biomedicals Asia Pacific Pte Ltd received an FDA warning letter?
No FDA warning letter addressed to the name "MP Biomedicals Asia Pacific Pte 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 MP Biomedicals Asia Pacific Pte Ltd received an FDA Form 483?
FDA has published 1 Form 483 for MP Biomedicals Asia Pacific Pte Ltd in its reading room, the most recent dated Mar 21, 2025. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect MP Biomedicals Asia Pacific Pte Ltd?
The most recent FDA inspection on file ended Mar 21, 2025 at Singapore, Singapore and was classified VAI. FDA has 3 inspections of MP Biomedicals Asia Pacific Pte Ltd on file.
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