FDA Inspection
Dae Shin Enterprise Co., Ltd.Dae Shin Enterprise Co., Ltd. – FDA Inspection, Apr 12, 2013
Record Details
This FDA Inspection record concerns Dae Shin Enterprise Co., Ltd., with an inspection on April 12, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- April 12, 2013
- Product Type
- Devices
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ID · ef466fc1-e8b4-4bcd-a790-6eeb96837b2f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 834991
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
FDA Citations
9- 21 CFR 1010.2(b)Certification label or tag
- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 1040.11(a)(1)Med. laser compliance, measurement
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