FDA Inspection
High Spot Health Technology Co. Ltd.High Spot Health Technology Co. Ltd. – FDA Inspection, Apr 15, 2015
Record Details
This FDA Inspection record concerns High Spot Health Technology Co. Ltd., with an inspection on April 15, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- April 15, 2015
- Product Type
- Devices
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ID · ad75ce62-bbf7-4839-a415-c48b6e0c3972
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 923423
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
11- 21 CFR 820.80(b)Incoming acceptance records, documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.75(a)Documentation
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