Company
ChinaGuangzhou Fortunique Limited, Guangzhou, China – FDA Inspections
Inspection records and compliance data for Guangzhou Fortunique Limited in Guangzhou. 2 FDA inspections on record, 1 Form 483, last inspected February 14, 2018.
Company Profile
This profile covers Guangzhou Fortunique Limited based in Guangzhou, China.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected November 14, 2013. Last inspected February 14, 2018.
Most cited issue areas
- Acceptance records1 inspection
- Design validation - user needs and intended uses1 inspection
- Lack of or inadequate process validation1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 14, 2018 | Not classified | Medical Devices & Rad Health | 1044480 |
| November 14, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 856751 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Guangzhou Fortunique Limited
FEI Number
3003915904
Address
Building 4, No. 202 Shiyulu; Fanyu, Guangzhou, China
Country
China
ID: d9aeaf16-c946-4808-831c-c4ccc278ce35