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483
•Ana J. Fandino•May 22, 2013

Ana J. Fandino – FDA 483, May 22, 2013

Record Details

An FDA inspection of Ana J. Fandino, Clinical Investigator, in Miami, FL, revealed significant deviations in the conduct of clinical investigations. The firm failed to adhere to investigational plans, exhibited poor record-keeping practices with inaccurate data entry, and maintained inadequate security for controlled investigational drugs, leading to theft. These findings indicate serious non-compliance with clinical research requirements.

Company
Ana J. Fandino
Inspection date
May 22, 2013
Product type
drugs
Office
Office of Medical Device and Radiological Health Division II
Person
  • Craig A. Garmendia (investigator)
View Company Profile

ID · 49c5b140-ea8f-4005-8844-219832694963

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