FDA Inspection
Neusoft Medical Systems Co., Ltd.Neusoft Medical Systems Co., Ltd. – FDA Inspection, Jan 29, 2016
Record Details
This FDA Inspection record concerns Neusoft Medical Systems Co., Ltd., with an inspection on January 29, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- January 29, 2016
- Product Type
- Devices
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ID · f9cc141b-5edc-4fab-8bf9-6095244bce8a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 957490
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
7- 21 CFR 806.20(b)(4)Justification for not reporting
- 21 CFR 1020.30(k)Compliance measurements--diagnostic source assembly
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.30(h)Incorrect translation to production specifications
- 21 CFR 803.17(a)(3)Lack of System for Timely Submission of Reports
- 21 CFR 1002.20(a)Failure to report
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Neusoft Medical Systems Co., Ltd.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| January 24, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 4, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 2, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 3, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Neusoft Medical Systems Co., Ltd.
- FDA Inspection 1083050 - 2019-01-24
- FDA Inspection 957496 - 2016-02-04
- FDA Inspection 844103 - 2013-08-02
- FDA Inspection 667977 - 2010-06-03
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