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483
•Veterans Administration Long Beach Healthcare System IRB•May 17, 2019

FDA 483 - Veterans Administration Long Beach Healthcare System IRB - May 17, 2019

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Record Details

An FDA inspection of the Veterans Administration Long Beach Healthcare System IRB identified a significant issue regarding recordkeeping. The facility failed to maintain copies of all research proposals reviewed and approved sample consent documents. This indicates a deficiency in the IRB's documentation practices for clinical investigations.

Company
Veterans Administration Long Beach Healthcare System IRB
Inspection Date
May 17, 2019
Product Type
Other
Office
Division of Pharmaceutical Quality Operations IV
Person
  • Lakecha N. Lewis (Business Analyst/Provider Enrollment Specialist)
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ID · b04c73c9-110b-4eb2-a8f6-a2ec7e919c8c

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