FDA Inspection
Beijing Toplaser Technology Co., Ltd.Beijing Toplaser Technology Co., Ltd. – FDA Inspection, Dec 1, 2011
Record Details
This FDA Inspection record concerns Beijing Toplaser Technology Co., Ltd., with an inspection on December 1, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- December 1, 2011
- Product Type
- Devices
View Company Profile
ID · e7eae36b-48f7-46ad-a78e-f7a81ffdad41
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 756492
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 1010.2(b)Certification label or tag
- 21 CFR 1010.3(a)ID label or tag
- 21 CFR 1040.10(g)(3)Class IV "Danger" label
- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 1002.13Failure to submit
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Other FDA inspections of Beijing Toplaser Technology Co., Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 2, 2015 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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