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FDA Inspection
•Med-Dyne, Inc.•January 30, 2023

Med-Dyne, Inc. – FDA Inspection, Jan 30, 2023

Record Details

This FDA Inspection record concerns Med-Dyne, Inc., with an inspection on January 30, 2023, issued by the Center for Devices and Radiological Health, covering devices.

Company
Med-Dyne, Inc.
Inspection Date
January 30, 2023
Product Type
Devices
Office
Center for Devices and Radiological Health
Person
  • Shannon A. Gregory (Investigator)
View Company Profile

ID · 76f40d6a-7453-4efb-af08-d16ad786d919

Inspection Facts

No Action Indicated (NAI)

No objectionable conditions or practices were found during the inspection.

Inspection number
1195952
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices
Outcome
Form 483 issued

FDA Citations

1
  1. 21 CFR 803.17(a)(1)Lack of System for Event Evaluations

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Med-Dyne, Inc.

4
DateClassificationOfficeProject area
November 6, 2025Not classifiedCincinnati District Office
May 21, 2019NAICenter for Devices and Radiological HealthCompliance: Devices
November 1, 2016NAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
June 15, 2011VAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for Med-Dyne, Inc.
  • FDA Inspection 1289796 - 2025-11-06
  • FDA Inspection 1091481 - 2019-05-21
  • FDA Inspection 999363 - 2016-11-01
  • FDA Inspection 728705 - 2011-06-15

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