FDA Inspection
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co. LtdCSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co. Ltd – FDA Inspection, Nov 11, 2025
Record Details
This FDA Inspection record concerns CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co. Ltd, with an inspection on November 11, 2025, issued by the Office of Inspections and Investigations, covering human drugs.
- Inspection Date
- November 11, 2025
- Product Type
- Human Drugs
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ID · 4e481189-7cc5-4516-86ff-034ad6970fe6
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1292466
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.42(c)(10)(v)Cleaning System
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Other FDA inspections of CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co. Ltd
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 26, 2024 | Not classified | Office of Inspections and Investigations | |
| March 27, 2015 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| July 26, 2012 | NAI | Center for Veterinary Medicine | Pre-Approval Eval. of Animal Drugs and Food Additives |
Other documents for CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co. Ltd
- FDA Inspection 1239624 - 2024-08-26
- FDA Inspection 921104 - 2015-03-27
- FDA Inspection 795286 - 2012-07-26
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