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FDA Inspection
•Lowell General Hospital/IRB•August 11, 2009

Lowell General Hospital/IRB – FDA Inspection, Aug 11, 2009

Record Details

This FDA Inspection record concerns Lowell General Hospital/IRB, with an inspection on August 11, 2009, issued by the Center for Devices and Radiological Health, covering devices.

Company
Lowell General Hospital/IRB
Inspection Date
August 11, 2009
Product Type
Devices
Office
Center for Devices and Radiological Health
View Company Profile

ID · 8883b43f-1270-469c-b70d-d3557d53f29a

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
604793
FDA center
Medical Devices & Rad Health
Project area
Bioresearch Monitoring

FDA Citations

2
  1. 21 CFR 56.115(a)(2)Minutes of IRB meetings
  2. 21 CFR 56.109(a)Authority of the IRB

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Lowell General Hospital/IRB

1
DateClassificationOfficeProject area
March 11, 2015NAIBioresearch Monitoring
Other documents for Lowell General Hospital/IRB
  • FDA Inspection 920098 - 2015-03-11

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