FDA Inspection
Guangdong Transtek Medical Electronics Co., Ltd.Guangdong Transtek Medical Electronics Co., Ltd. – FDA Inspection, Apr 6, 2017
Record Details
This FDA Inspection record concerns Guangdong Transtek Medical Electronics Co., Ltd., with an inspection on April 6, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- April 6, 2017
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 75f550ee-3fb5-4c3d-9700-8027196fd348
Inspection Facts
- Inspection number
- 1010444
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 820.30(f)Design verification - documentation
- 21 CFR 820.30(g)Design validation - documentation
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Other FDA inspections of Guangdong Transtek Medical Electronics Co., Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 25, 2024 | Not classified | Office of Inspections and Investigations |
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