FDA Warns Foreign Personal-Care Firms For Monograph, GMP Violations

摘要

FDA's warning letter to Spanish firm Jabones Pardo S.A. cites violations of the OTC topical acne product monograph and good manufacturing practices, marking continued agency enforcement against foreign personal-care manufacturers. The Aug. 22 letter to the Madrid-based firm is the latest in a string of FDA warnings to international firms that have run afoul of U.S. drug regulations due to their personal-care product formulations, labeling and manufacturing processes.