Newspaper article from our research archive:

7-item 483 delivered to clinical investigator for protocol violations.(Clinical investigators)

Kim Hendrick, M.D., Flushing, MI, was hit with a seven-item 483 because the clinical investigator failed to adhere to protocol in the area of independent radiological assessments of sinus X-rays. Investigator Laureen Kononen from the Detroit, MI, District Office conducted the inspection.

"The radiological group listed in the sinus x-ray assessments did not perform radiological interpretations of enrolled subjects as submitted to the sponsor by Dr. Hendrick's office," according to FDA documents. Assessments were noted for several screen failure subjects at that facility.

"Source documentation of x-ray interpretations by the radiological group listed on the assessments ...

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