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FDA Inspection
•Mykon International Inc.•December 3, 2009

Mykon International Inc. – FDA Inspection, Dec 3, 2009

Record Details

This FDA Inspection record concerns Mykon International Inc., with an inspection on December 3, 2009, issued by the Center for Devices and Radiological Health, covering devices.

Company
Mykon International Inc.
Inspection Date
December 3, 2009
Product Type
Devices
Office
Center for Devices and Radiological Health
View Company Profile

ID · 77a73fa7-2e45-4b33-a108-1d533e1e81e7

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
632591
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices

FDA Citations

1
  1. 21 CFR 803.17(a)(3)Lack of System for Timely Submission of Reports

Full citation text and observation details available on the Dashboard.

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