FDA Inspection
Tianjin Kingyork Pharmaceuticals Co., LtdTianjin Kingyork Pharmaceuticals Co., Ltd – FDA Inspection, Jul 31, 2026
Record Details
This FDA Inspection record concerns Tianjin Kingyork Pharmaceuticals Co., Ltd, with an inspection on July 31, 2026, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 3d5878fd-dc96-448b-8ec6-827a07ca5b38
Inspection Facts
- Inspection number
- 1331476
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(c)Approve or reject procedures or specs
- 21 CFR 211.42(c)(10)(v)Cleaning System
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Other FDA inspections of Tianjin Kingyork Pharmaceuticals Co., Ltd
6| Date | Classification | Office | Project area |
|---|---|---|---|
| July 26, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 27, 2019 | Not classified | Office of Inspections and Investigations | |
| May 31, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 29, 2018 | Not classified | Office of Inspections and Investigations | |
| September 1, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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