FDA Inspection
Omni Components CorporationOmni Components Corporation – FDA Inspection, Aug 31, 2017
Record Details
This FDA Inspection record concerns Omni Components Corporation, with an inspection on August 31, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- James W. Whitney (Issuing Officer)
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ID · 6c4ee3b2-51d7-4713-bb63-cbe95cc90bc1
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1023693
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.72(b)Calibration procedures - content
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