FDA hits CDMO Ei for making drugs and pesticides with same equipment

fda
The plant, which produces finished pharmaceuticals, was inspected in early October 2017. (FDA)

The FDA hit Ei, a CDMO, with a warning letter for manufacturing pharmaceuticals in the same building and with the same equipment it uses to produce pesticides.

In its letter posted to the regulatory agency’s website, the FDA outlined poor manufacturing procedures at the company’s facility located in Kannapolis, North Carolina. The plant, which produces finished pharmaceuticals like liquid and semisolid topical drugs, was inspected in early October 2017.

The agency said inspectors found the company “manufactured topical human drugs and several pesticides in the same building, using shared equipment” despite the risk of cross contamination. Inspectors also found two of the drugs meant for human use contained a pesticide produced at the facility.

Webinar This Week

OTC Innovation to Avoid Stagnation: Survey Insights, Expert Advice, and Latest Technologies to Boost Your Product’s Performance

Join us for a complimentary webinar on November 13 at 11am ET / 8am PT. Listen to industry experts as they analyze the critical role of innovation in OTC products, and strategies for achieving it.

Additionally, the agency said Ei didn’t have or follow correct procedures for cleaning and maintaining the equipment, and failed to investigate any “unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications.”

“Our investigator also found evidence of contamination from unknown impurities in six engineering batches of clobetasol propionate 0.05% topical spray,” the agency wrote. “You produced these drug products using the same equipment and facilities that you use for commercial manufacturing.”

The FDA recommended Ei hire an outside consultant to help them with the issues.

Suggested Articles

Lonza CEO Marc Funk is leaving for "personal reasons" after less than a year in the top job. 

Drugmakers have voluntarily recalled their generic Zantac from the U.S. market after the FDA raised concerns, but it has not been without a cost.

Just weeks after selling the sterile manufacturing assets of its Kyowa operation in Japan, it has unloaded the rest of its Kyowa drugmaking operation.