A North Carolina drug manufacturing facility is in the hot seat after an October FDA inspection found it was producing topical human drugs and pesticides using the same equipment.
The agency also observed that Ei LLC did not complete timely investigations of possible contamination. For example, it left the investigation of an unknown impurity in a topical drug open for at least 14 months, and did not implement corrective and preventive actions.
The agency discovered that the firm did not validate its cleaning procedures to make sure no cross contamination occurred in human drugs manufactured at the facility or evaluate the potential cross-contamination of its human drugs with other human drugs.
The agency asked the company to provide a plan for how it will maintain separate and dedicated manufacturing equipment for its pesticide and pharmaceutical operations if it plans to continue manufacturing both types of products at the facility.
It also requested that the firm test its human drugs for pesticides and conduct risk assessments for all drugs previously manufactured with equipment used in pesticide production.