The FDA served Wells Pharmacy Network with a six-observation Form 483 for failing to maintain adequate sterility controls and an acceptable state of repair at its Tennessee facility. 

A September inspection revealed that the company lacks procedures to prevent microbiological contamination and dedicated equipment for each of the drugs it manufactures to prevent cross-contamination. The company’s drug containers have also not undergone decontamination to remove bacterial pyrogens, such as endotoxins and exotoxins, the agency said.

FDA investigators additionally noted that Wells Pharmacy additionally failed to use a sporicidal agent to disinfect its cleanroom and conduct smokes studies under dynamic conditions to test the airflow of the facility.