FDA Inspection
Beijing Syntech Laser Co., LtdBeijing Syntech Laser Co., Ltd – FDA Inspection, Jul 12, 2013
Record Details
This FDA Inspection record concerns Beijing Syntech Laser Co., Ltd, with an inspection on July 12, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- July 12, 2013
- Product Type
- Devices
View Company Profile
ID · 9690537d-9217-4271-a69f-029fcbd2c530
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 841544
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
FDA Citations
7- 21 CFR 820.100(a)(4)CAPA verification/validation of corrective/preventive action
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.100(a)(1)Analysis of data/reports from data sources
- 21 CFR 1040.10(h)(1)(iv)User info - list controls, etc.
- 21 CFR 1040.10(h)(2)(i)Reproduction of affixed information
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
- 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 7, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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