FDA 483 - Shireen V. Guide, M.D. - October 07, 2022

An FDA inspection of Shireen V. Guide, M.D. in Rancho Santa Margarita, CA, a clinical investigator, revealed significant deviations from the investigational plan. The observations included instances where subjects received incorrect investigational product, study drugs were not stored according to the pharmacy manual, and randomization dates were incorrectly documented. These issues indicate a failure to adhere to established protocols for clinical investigations.