FDA Inspection
MED&CARE (SHENZHEN) CO., LTD.MED&CARE (SHENZHEN) CO., LTD. – FDA Inspection, Dec 8, 2016
Record Details
This FDA Inspection record concerns MED&CARE (SHENZHEN) CO., LTD., with an inspection on December 8, 2016, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- December 8, 2016
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 69678cbd-7402-489a-9071-bf1840e227c0
Inspection Facts
- Inspection number
- 1022376
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation - user needs and intended uses
Full citation text and observation details available on the Dashboard.
Other FDA inspections of MED&CARE (SHENZHEN) CO., LTD.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 2, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for MED&CARE (SHENZHEN) CO., LTD.
- FDA Inspection 874846 - 2014-04-02
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.