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•United States

Lowell General Hospital/IRB, Lowell, MA – FDA Inspections

Inspection records and compliance data for Lowell General Hospital/IRB in Lowell, Massachusetts. 2 FDA inspections on record, last inspected March 11, 2015.

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Company Profile

This profile covers Lowell General Hospital/IRB based in Lowell, Massachusetts, United States.

FDA Inspection History

FDA inspections
2
OAI
0
VAI
1
NAI
1
Form 483s
0
Warning letters
0

First inspected August 11, 2009. Last inspected March 11, 2015.

Most cited issue areas

  • Authority of the IRB1 inspection
  • Minutes of IRB meetings1 inspection

FDA inspections (2)

DateResultFDA center(s)Insp. #
March 11, 2015NAIHuman Drugs, Medical Devices & Rad Health · Bioresearch Monitoring920098
August 11, 2009VAIMedical Devices & Rad Health · Bioresearch Monitoring604793
FDA documents

No Form 483s, Warning Letters or EIRs on record.

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Hardten, David R., MD, Clinical Investigator
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Sreenivasa R. Chandana, M.D., Ph.D.
Company Information

Name

Lowell General Hospital/IRB

FEI Number

1283783

Address

295 Varnum Ave, Lowell, Massachusetts 01854, United States

Country

United States

ID: de71969e-2d0a-4c39-bd76-902cec07e16e

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