Wuhan Biocause Pharmaceutical Development Co., Ltd. FDA Record
Wuhan Biocause Pharmaceutical Development Co., Ltd. has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Wuhan Biocause Pharmaceutical Development Co., Ltd." is on file.
- Latest inspection
- Mar 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 | 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 | 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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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Mar 14, 2025 | Wuhan, China | Drugs | Voluntary Action Indicated (VAI) | 3004202226 |
| Aug 24, 2018 | Wuhan, China | Drugs | Voluntary Action Indicated (VAI) | 3004202226 |
| Jul 22, 2016 | Wuhan, China | Drugs | Voluntary Action Indicated (VAI) | 3004202226 |
| Feb 28, 2014 | Wuhan, China | Drugs | Voluntary Action Indicated (VAI) | 3004202226 |
| Jul 23, 2010 | Wuhan, China | Drugs | Voluntary Action Indicated (VAI) | 3004202226 |
- 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 3004202226 | Wuhan, China | 5 | Mar 14, 2025 |
Wuhan Biocause Pharmaceutical Development Co., Ltd. and the FDA: common questions
Has Wuhan Biocause Pharmaceutical Development Co., Ltd. received an FDA warning letter?
No FDA warning letter addressed to the name "Wuhan Biocause Pharmaceutical Development Co., 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 Wuhan Biocause Pharmaceutical Development Co., Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "Wuhan Biocause Pharmaceutical Development Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Wuhan Biocause Pharmaceutical Development Co., Ltd.?
The most recent FDA inspection on file ended Mar 14, 2025 at Wuhan, China and was classified VAI. FDA has 5 inspections of Wuhan Biocause Pharmaceutical Development Co., Ltd. on file.
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