Company
ChinaHe Gao Plastic Factory, Shantou, China – FDA Inspections
Inspection records and compliance data for He Gao Plastic Factory in Shantou. 3 FDA inspections on record (2 OAI), 1 warning letter, last inspected November 09, 2016.
Company Profile
This profile covers He Gao Plastic Factory based in Shantou, China.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 2
- VAI
- 0
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 0
- Warning letters
- 1
First inspected December 21, 2011. Last inspected November 9, 2016.
Most cited issue areas
- Acceptance status1 inspection
- Documentation of validated process performance1 inspection
- Lack of or inadequate process validation1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 9, 2016 | Not classified | Medical Devices & Rad Health | 992549 |
| March 14, 2013 | OAI | Medical Devices & Rad Health · Compliance: Devices | 825428 |
| December 21, 2011 | OAI | Medical Devices & Rad Health · Compliance: Devices | 762201 |
FDA documents
Warning Letters (1)
People (1)
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Company Information
Name
He Gao Plastic Factory
FEI Number
3007608864
Address
Liangying Town, He Gao Village; Chaonan, Shantou, China
Country
China
ID: c5c9835e-ff35-4133-8d25-323a275ec7c3