FDA Inspection
Shanghai Kindly Enterprise Development Group Co., LtdShanghai Kindly Enterprise Development Group Co., Ltd – FDA Inspection, Jul 19, 2011
Record Details
This FDA Inspection record concerns Shanghai Kindly Enterprise Development Group Co., Ltd, with an inspection on July 19, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- July 19, 2011
- Product Type
- Devices
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ID · 89798c6e-afde-4cec-8ccf-cdf9869cc7dc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 735631
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
- 21 CFR 820.30(f)Design verification - documentation
- 21 CFR 820.40(a)Document review, approval documentation
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Other FDA inspections of Shanghai Kindly Enterprise Development Group Co., Ltd
3| Date | Classification | Office | Project area |
|---|---|---|---|
| April 19, 2024 | Not classified | Office of Inspections and Investigations | |
| August 9, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 10, 2013 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Shanghai Kindly Enterprise Development Group Co., Ltd
- FDA Inspection 1242617 - 2024-04-19
- FDA Inspection 1065879 - 2018-08-09
- FDA Inspection 853581 - 2013-10-10
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