FDA 483 - Sina Health Inc - January 13, 2023

Sina Health Inc., a repacker in Scottsdale, AZ, received a Form FDA 483 with four observations during an inspection from January 9-13, 2023. The inspection revealed significant deficiencies including the quality control unit's failure to approve written procedures, a lack of annual batch record evaluations, inadequate labeling control, and the absence of equipment calibration procedures. These findings indicate a general lack of adherence to established quality systems and good manufacturing practices.