FDA Inspection
GRI Medical & Electronic Technology Co., Ltd.GRI Medical & Electronic Technology Co., Ltd. – FDA Inspection, Dec 20, 2012
Record Details
This FDA Inspection record concerns GRI Medical & Electronic Technology Co., Ltd., with an inspection on December 20, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- December 20, 2012
- Product Type
- Devices
View Company Profile
ID · f2cbe5ac-5917-4c9d-95b7-d4c4dd7c7a63
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 813361
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
8- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.120(d)Records, DHR {see also 820.184(e)}
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.250(b)Sampling methods - Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.184DHR content
Full citation text and observation details available on the Dashboard.
Other FDA inspections of GRI Medical & Electronic Technology Co., Ltd.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| April 19, 2018 | Not classified | Office of Inspections and Investigations | |
| September 22, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 14, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for GRI Medical & Electronic Technology Co., Ltd.
- FDA Inspection 1087779 - 2018-04-19
- FDA Inspection 989002 - 2016-09-22
- FDA Inspection 896201 - 2014-08-14
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.