Hainan Simcere Pharmaceutical Co., Ltd. FDA Record
Hainan Simcere Pharmaceutical Co., Ltd. has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Hainan Simcere Pharmaceutical Co., Ltd." is on file.
- Latest inspection
- Apr 29, 2025 · NAI
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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 | 1 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Apr 29, 2025 | Haikou, China | Drugs | No Action Indicated (NAI) | 3015251693 |
- 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 3015251693 | Haikou, China | 1 | Apr 29, 2025 |
Hainan Simcere Pharmaceutical Co., Ltd. and the FDA: common questions
Has Hainan Simcere Pharmaceutical Co., Ltd. received an FDA warning letter?
No FDA warning letter addressed to the name "Hainan Simcere Pharmaceutical 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 Hainan Simcere Pharmaceutical Co., Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "Hainan Simcere Pharmaceutical Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Hainan Simcere Pharmaceutical Co., Ltd.?
The most recent FDA inspection on file ended Apr 29, 2025 at Haikou, China and was classified NAI. FDA has 1 inspection of Hainan Simcere Pharmaceutical Co., Ltd. on file.
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