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483
•Richard W. Foltin, Ph.D.•June 21, 2019

Richard W. Foltin, Ph.D. – FDA 483, Jun 21, 2019

Record Details

The FDA inspected Foltin Richard W in New York, NY, and issued a Form 483 with two observations. The inspection revealed that investigations were not conducted according to the investigational plan, with subjects enrolled despite not meeting exclusion criteria and vital signs being inconsistently recorded or altered. Additionally, the firm failed to maintain accurate case histories, showing discrepancies in recorded vital signs and their corresponding timestamps.

Company
Richard W. Foltin, Ph.D.
Inspection date
June 21, 2019
Product type
drugs
Office
Division of Human and Animal Food Operations - East I
People
  • Michelle C Roberts
  • Karen L. Kosar (Investigator )
  • Omadevi Somai
View Company Profile

ID · c247810a-a983-49a0-b680-b9135befa765

Other documents for Richard W. Foltin, Ph.D.
  • 483 - 2023-03-17March 17, 2023
  • WARNING_LETTER - 2023-03-17March 17, 2023

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