FDA Inspection
KLC Services IncKLC Services Inc – FDA Inspection, Jan 23, 2017
Record Details
This FDA Inspection record concerns KLC Services Inc, with an inspection on January 23, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 1a6c6091-889c-4c97-abe4-ab4bdd6db0da
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 998818
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 820.40Lack of procedures, or not maintained
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