FDA Inspection
Hangzhou Jinlin Medical Appliances Co., Ltd.Hangzhou Jinlin Medical Appliances Co., Ltd. – FDA Inspection, Jul 26, 2012
Record Details
This FDA Inspection record concerns Hangzhou Jinlin Medical Appliances Co., Ltd., with an inspection on July 26, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- July 26, 2012
- Product Type
- Devices
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ID · 5e763bb3-0e45-4954-9c24-0a850af6352f
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 795124
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
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Other FDA inspections of Hangzhou Jinlin Medical Appliances Co., Ltd.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 19, 2025 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 1, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Hangzhou Jinlin Medical Appliances Co., Ltd.
- FDA Inspection 1271610 - 2025-03-19
- FDA Inspection 1074030 - 2018-11-01
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