FDA Inspection
Kinetic Research, Inc.Kinetic Research, Inc. – FDA Inspection, Sep 9, 2015
Record Details
This FDA Inspection record concerns Kinetic Research, Inc., with an inspection on September 9, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Kinetic Research, Inc.
- Inspection Date
- September 9, 2015
- Product Type
- Devices
View Company Profile
ID · 2b713aee-0e0b-4011-8412-c54196b5fc4f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 941332
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.198(b)Review and evaluation for investigation
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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