Korean Manufacturer Warned for Quality Control, Drug Storage
December 11, 2018
The FDA hit Korean drug supplier Barox with a warning letter for quality control, drug labeling and product storage issues at its Seongnam, Gyeonggi facility.
The firm, which relabels OTC drug products made by a contract manufacturer and markets them in the U.S., didn’t have written documents describing the roles and responsibilities of its quality control unit, an inspection found.
“All of your employees, including those in the QCU, lack knowledge of CGMP requirements,” the agency said, instructing the firm to write a detailed description of its quality unit responsibilities and to train its employees in CGMPs.