Company
ChinaJiangsu Guangda Medical Material Group Co., Ltd., Nantong, China – FDA Inspections
Inspection records and compliance data for Jiangsu Guangda Medical Material Group Co., Ltd. in Nantong. 4 FDA inspections on record, 1 Form 483, last inspected August 31, 2023.
Company Profile
This profile covers Jiangsu Guangda Medical Material Group Co., Ltd. based in Nantong, China.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 3
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected September 19, 2012. Last inspected August 31, 2023.
Most cited issue areas
- Lack of or inadequate procedures2 inspections
- Design validation- Lack of or inadequate procedures1 inspection
- Design validation - user needs and intended uses1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 31, 2023 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1217706 |
| December 5, 2018 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1081397 |
| April 10, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 926501 |
| September 19, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 802595 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Jiangsu Guangda Medical Material Group Co., Ltd.
FEI Number
3006847952
Address
Libao, No 18 Baochang North Rd; Libaozhen Haianxian, Nantong, China
Country
China
ID: c78215be-a665-46f2-a5cf-c348d8b3590b