FDA 483 - WellRx LLC - November 19, 2015

This FDA Form 483 document details observations from an inspection of Wellcare Rx Investments LLC dba Denson's Specialty Pharmacy, a producer of sterile drugs, located at 200 E Willow Ave, Wheaton, IL. The inspection occurred from August 12, 2015, to November 19, 2015.

The inspection revealed numerous deficiencies across various aspects of sterile drug production:

**Product Quality and Contamination:** * **Observation 1:** A vial of sterile Chlorpromazine HCL 25mg/ml (lot# 05-070815) was observed with visible particles. * **Observation 2:** Procedures to prevent microbiological contamination during aseptic preparation were not established or followed, including lack of documented ISO-5 laminar air flow hood decontamination, failure to decontaminate sterile item packages before introduction into the hood, and opening sterile packages outside the hood. * **Observation 3:** Protective apparel worn by personnel during aseptic processing was inadequate (non-sterile gowns, masks, bonnets, booties; exposed skin; sterile gloves opened outside the hood). * **Observation 18:** The system for cleaning and disinfecting the cleanroom and equipment to produce aseptic conditions was deficient.

**Environmental and Personnel Monitoring:** * **Observation 4:** Aseptic processing areas lacked a system for monitoring environmental conditions. The firm had never performed environmental monitoring