FDA posted 9 warning letters last week, one of which was issued to a clinical investigator.

CLINICAL INVESTIGATOR:

  • Corona Doctors Medical Clinics, Inc (Corona, CA) received a warning letter on November 16, 2018 based on the outcome of an inspection ending June 27, 2018. Deficiencies include but are not limited to the following:
    • Clinical study drug was administered to six subjects after the study was placed on clinical hold and this hold was repeatedly communicated to the site, both verbally and in writing. In one case the study drug was administered just a few hours after the FDA notified the firm in a teleconference that they were on clinical hold.
    • Two subjects received study drug prior to the IND going into effect.