FDA Inspection
Mantra Intl. (HK) Ltd. - DongGuan branch officeMantra Intl. (HK) Ltd. - DongGuan branch office – FDA Inspection, Jun 24, 2010
Record Details
This FDA Inspection record concerns Mantra Intl. (HK) Ltd. - DongGuan branch office, with an inspection on June 24, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- June 24, 2010
- Product Type
- Devices
View Company Profile
ID · 525f0c81-b7cd-48a9-9e00-8a3fde790030
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 680915
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
9- 21 CFR 820.100(b)Documentation
- 21 CFR 820.40(a)Document review, approval by designated individual
- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.20(a)Management ensuring quality policy is understood
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
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Other FDA inspections of Mantra Intl. (HK) Ltd. - DongGuan branch office
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 20, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Mantra Intl. (HK) Ltd. - DongGuan branch office
- FDA Inspection 886460 - 2014-06-20
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