Hebei Changshan Biochemical Pharmaceutical Co., Ltd. FDA Record
Hebei Changshan Biochemical Pharmaceutical Co., Ltd. has 0 FDA recalls, 4 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Hebei Changshan Biochemical Pharmaceutical Co., Ltd." is on file.
- Latest inspection
- Apr 5, 2024 · NAI
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 | 4 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Apr 5, 2024 | Shijiazhuang, China | Drugs | No Action Indicated (NAI) | 3010849972 |
| Apr 6, 2016 | Shijiazhuang, China | Drugs | No Action Indicated (NAI) | 3005080039 |
| Apr 17, 2015 | Shijiazhuang, China | Drugs | No Action Indicated (NAI) | 3010849972 |
| Sep 15, 2011 | Shijiazhuang, China | Drugs | No Action Indicated (NAI) | 3005080039 |
- 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 3010849972 | Shijiazhuang, China | 2 | Apr 5, 2024 |
| FEI 3005080039 | Shijiazhuang, China | 2 | Apr 6, 2016 |
Hebei Changshan Biochemical Pharmaceutical Co., Ltd. and the FDA: common questions
Has Hebei Changshan Biochemical Pharmaceutical Co., Ltd. received an FDA warning letter?
No FDA warning letter addressed to the name "Hebei Changshan Biochemical 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 Hebei Changshan Biochemical Pharmaceutical Co., Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "Hebei Changshan Biochemical Pharmaceutical Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Hebei Changshan Biochemical Pharmaceutical Co., Ltd.?
The most recent FDA inspection on file ended Apr 5, 2024 at Shijiazhuang, China and was classified NAI. FDA has 4 inspections of Hebei Changshan Biochemical Pharmaceutical Co., Ltd. on file.
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