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FDA Inspection
•Mark S. Slaughter MD•May 2, 2017

Mark S. Slaughter MD – FDA Inspection, May 2, 2017

Record Details

This FDA Inspection record concerns Mark S. Slaughter MD, with an inspection on May 2, 2017, issued by the Center for Devices and Radiological Health, covering devices.

Company
Mark S. Slaughter MD
Inspection Date
May 2, 2017
Product Type
Devices
Office
Center for Devices and Radiological Health
Person
  • Karen M. Cooper (Company Rep)
View Company Profile

ID · ef80a99c-c70f-4aa9-b471-c3da531ce1a1

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1011489
FDA center
Medical Devices & Rad Health
Project area
Project Evaluation: Devices
Outcome
Form 483 issued

FDA Citations

3
  1. 21 CFR 812.110(b)Investigator non-compliance with agreement/plan/regulations
  2. 21 CFR 812.140(a)(2)(ii)Investigator records of persons receiving devices inadequate
  3. 21 CFR 812.140(a)(2)(i)Investigator device accountability inadequate

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Mark S. Slaughter MD

1
DateClassificationOfficeProject area
November 8, 2010NAICenter for Devices and Radiological HealthBioresearch Monitoring
Other documents for Mark S. Slaughter MD
  • FDA Inspection 697315 - 2010-11-08

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