FDA Inspection
Amsino Medical (Kunshan) Co., Ltd.Amsino Medical (Kunshan) Co., Ltd. – FDA Inspection, Nov 4, 2010
Record Details
This FDA Inspection record concerns Amsino Medical (Kunshan) Co., Ltd., with an inspection on November 4, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- November 4, 2010
- Product Type
- Devices
View Company Profile
ID · e2fd61a7-ce93-4562-a1d7-e498ab1b526c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 708717
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.150Lack of or inadequate procedures for storage.
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Amsino Medical (Kunshan) Co., Ltd.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 14, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 12, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 12, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Amsino Medical (Kunshan) Co., Ltd.
- FDA Inspection 1059046 - 2018-06-14
- FDA Inspection 975320 - 2016-05-12
- FDA Inspection 852513 - 2013-09-12
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.