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FDA Inspection
•Trinity Medical Center-IRB•July 27, 2018

Trinity Medical Center-IRB – FDA Inspection, Jul 27, 2018

Record Details

This FDA Inspection record concerns Trinity Medical Center-IRB, with an inspection on July 27, 2018, issued by the Center for Devices and Radiological Health, covering devices.

Company
Trinity Medical Center-IRB
Inspection Date
July 27, 2018
Product Type
Devices
Office
Center for Devices and Radiological Health
Person
  • Lequita M. Mayhew (Issuing Officer)
View Company Profile

ID · 6bc6905c-ecf9-4855-bb23-fa4411c3fa32

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1060183
FDA center
Medical Devices & Rad Health
Project area
Bioresearch Monitoring
Outcome
Form 483 issued

FDA Citations

1
  1. 21 CFR 56.115(b)Retention of records

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Trinity Medical Center-IRB

1
DateClassificationOfficeProject area
June 24, 2011VAICenter for Devices and Radiological HealthBioresearch Monitoring
Other documents for Trinity Medical Center-IRB
  • FDA Inspection 729057 - 2011-06-24

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