FDA Inspection
GYMMAX TECHNOLOGY SHENZHEN CO., LTD.GYMMAX TECHNOLOGY SHENZHEN CO., LTD. – FDA Inspection, Jun 15, 2017
Record Details
This FDA Inspection record concerns GYMMAX TECHNOLOGY SHENZHEN CO., LTD., with an inspection on June 15, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- June 15, 2017
- Product Type
- Medical Devices & Rad Health
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ID · f8c43adb-987b-40ef-ad74-2e87650d7b92
Inspection Facts
- Inspection number
- 1016646
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of GYMMAX TECHNOLOGY SHENZHEN CO., LTD.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 23, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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