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483
•Dipakkumar P. Pandya, M.D.•February 1, 2024

FDA 483 - Dipakkumar P. Pandya, M.D. - February 01, 2024

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Record Details

An FDA inspection of Dipakkumar P. Pandya, M.D. in Annandale, NJ, revealed significant deviations from clinical study protocols and inadequate record-keeping. The firm failed to conduct required safety assessments, monitor investigational product storage, and maintain complete and correct informed consent forms and subject data. These issues indicate a lack of adherence to good clinical practice during the study.

Company
Dipakkumar P. Pandya, M.D.
Inspection Date
February 1, 2024
Product Type
Drugs
Office
New Jersey District Office
People
  • Michael Serrano (investigator)
  • Jay B. Shah (Investigator)
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ID · c13ee1be-222d-4b62-ad8f-f8aa2b49ca31

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