FDA 483 - Pharmacy Doctors Enterprises dba Zion Clinic Pharmacy - November 20, 2017

On November 7-9, 13-16, and 20, 2017, the FDA inspected Pharmacy Doctors Enterprises dba Zion Clinical Pharmacy, located at 205 East Hallandale Beach Blvd., Hallandale Beach, FL 33009. The firm, identified by FEI number 3013918415, produces sterile and non-sterile drugs. The inspection report was issued to Veronica Taran, President and Owner.

The inspection revealed one observation: highly potent drugs (buprenorphine HCl) and hazardous drugs (human chorionic gonadotropin - HCG) were produced without adequate containment, segregation, and/or cleaning to prevent cross-contamination.

Specific issues included: * The equipment washing area, a single-basin hand wash sink, is in the ISO 7 ante-room adjacent to the ISO 7 buffer room, with the buffer room door opening towards the sink and recirculating airflow. * Sporicidal agents are not used in the facility's clean rooms or ISO 5 area. * The facility's design and operation permit poor personnel and material flow, with non-sterile processing components stored in the ISO 7 ante-room. This storage may increase dust, humidity, and temperature, potentially elevating bacterial and fungal bio-burden.

Affected sterile and non-sterile human and animal drug preparations include buprenorphine H