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FDA Inspection
•Stuart A. Harlin, MD•May 21, 2010

Stuart A. Harlin, MD – FDA Inspection, May 21, 2010

Record Details

This FDA Inspection record concerns Stuart A. Harlin, MD, with an inspection on May 21, 2010, issued by the Center for Devices and Radiological Health, covering devices.

Company
Stuart A. Harlin, MD
Inspection Date
May 21, 2010
Product Type
Devices
Office
Center for Devices and Radiological Health
View Company Profile

ID · 90a8ed81-b4f1-4742-9fb1-c04e699f8457

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number
663442
FDA center
Medical Devices & Rad Health
Project area
Bioresearch Monitoring

FDA Citations

4
  1. 21 CFR 812.110(b)Investigator non-compliance with agreement/plan/regulations
  2. 21 CFR 812.150(a)(2)Investigator report of IRB withdrawal of approval
  3. 21 CFR 812.140(a)(3)Investigator"s subject records inadequate
  4. 21 CFR 812.140(d)Record retention inadequate

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Stuart A. Harlin, MD

1
DateClassificationOfficeProject area
June 20, 2014VAICenter for Devices and Radiological HealthBioresearch Monitoring
Other documents for Stuart A. Harlin, MD
  • FDA Inspection 884382 - 2014-06-20

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