FDA Inspection
Beijing Syntech Laser Co., LtdBeijing Syntech Laser Co., Ltd – FDA Inspection, Jul 7, 2017
Record Details
This FDA Inspection record concerns Beijing Syntech Laser Co., Ltd, with an inspection on July 7, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · a73dee04-4fc2-41cb-aee3-e2794f61ba03
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1019784
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 1010.2(b)Certification label or tag
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 1002.13Failure to submit
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Other FDA inspections of Beijing Syntech Laser Co., Ltd
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 12, 2013 | VAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
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