FDA 483 - John's Pharmacy Inc. - February 22, 2019

John's Pharmacy Inc. in Sullivan, IL, a producer of non-sterile drugs, was cited for two significant issues during an FDA inspection. The firm used non-pharmaceutical grade water in drug production without microbial quality testing or proper maintenance records, and failed to adequately clean work surfaces and utensils when producing hazardous drugs, posing a risk of cross-contamination. These observations indicate deficiencies in component control and facility sanitation practices.