Device Maker’s Ex-Employee Pleads Guilty To Faking FDA 510(k) Clearance Letters

(July 21, 2023, 12:09 PM EDT) -- ALLENTOWN, Pa. — A former regulatory affairs specialist for a U.S. subsidiary of drug and medical device maker B. Braun AG pleaded guilty on July 20 in a Pennsylvania federal court to one count of violating the Food, Drug and Cosmetic Act (FDCA) by counterfeiting and forging FDA clearance letters for two medical devices and making the devices adulterated and misbranded....

Attached Documents

Related Sections