Company
ChinaMantra Intl. (HK) Ltd. - DongGuan branch office, Dongguan, China – FDA Inspections
Inspection records and compliance data for Mantra Intl. (HK) Ltd. - DongGuan branch office in Dongguan. 2 FDA inspections on record, last inspected June 20, 2014.
Company Profile
This profile covers Mantra Intl. (HK) Ltd. - DongGuan branch office based in Dongguan, China.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected June 24, 2010. Last inspected June 20, 2014.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Documentation1 inspection
- Document review, approval by designated individual1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 20, 2014 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 886460 |
| June 24, 2010 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 680915 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Mantra Intl. (HK) Ltd. - DongGuan branch office
FEI Number
3003741750
Address
Humen Town, A, Yayao Factory, Huaiya Road; Zone Huaide Management District, Dongguan, China
Country
China
ID: da67004c-6f96-460c-a3e7-3dfeb7d5cb16