FDA Inspection
OCCK IncOCCK Inc – FDA Inspection, Aug 7, 2018
Record Details
This FDA Inspection record concerns OCCK Inc, with an inspection on August 7, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e7863d39-490e-429f-a9dc-9eebfb12f05f
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1061362
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184DHR content
- 21 CFR 820.20(b)(3)Management representative
- 21 CFR 820.40Lack of procedures, or not maintained
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