FDA Inspection
SHENZHEN LAUNCH ELECTRIAL CO., LTDSHENZHEN LAUNCH ELECTRIAL CO., LTD – FDA Inspection, Apr 21, 2016
Record Details
This FDA Inspection record concerns SHENZHEN LAUNCH ELECTRIAL CO., LTD, with an inspection on April 21, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- April 21, 2016
- Product Type
- Devices
View Company Profile
ID · b1914132-2798-44a3-b64b-df5f1a66f6d6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 968596
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.198(b)Review and evaluation for investigation
- 21 CFR 820.25(b)Training records
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184DHR content
- 21 CFR 803.17Lack of Written MDR Procedures
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