Lonza Biologics Tuas Pte Ltd FDA Record
Lonza Biologics Tuas Pte Ltd has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Lonza Biologics Tuas Pte Ltd" is on file.
- Latest inspection
- Jun 27, 2023 · 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 | 5 | 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 | 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 | 1 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jun 27, 2023 | Singapore, Singapore | Drugs | Voluntary Action Indicated (VAI) | 3009725845 |
| Sep 20, 2019 | Singapore, Singapore | Drugs | Voluntary Action Indicated (VAI) | 3009725845 |
| Feb 24, 2017 | Singapore, Singapore | Drugs | No Action Indicated (NAI) | 3009725845 |
| Mar 10, 2015 | Singapore, Singapore | Drugs | Voluntary Action Indicated (VAI) | 3009725845 |
| Aug 3, 2012 | Singapore, Singapore | Drugs | Voluntary Action Indicated (VAI) | 3009725845 |
- 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 3009725845 | Singapore, Singapore | 5 | Jun 27, 2023 |
Lonza Biologics Tuas Pte Ltd and the FDA: common questions
Has Lonza Biologics Tuas Pte Ltd received an FDA warning letter?
No FDA warning letter addressed to the name "Lonza Biologics Tuas 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 Lonza Biologics Tuas Pte Ltd received an FDA Form 483?
FDA has not published a Form 483 for "Lonza Biologics Tuas Pte Ltd" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Lonza Biologics Tuas Pte Ltd?
The most recent FDA inspection on file ended Jun 27, 2023 at Singapore, Singapore and was classified VAI. FDA has 5 inspections of Lonza Biologics Tuas Pte Ltd on file.
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