US FDA slams Korean OTC maker: All employees ‘lack knowledge of GMP requirements’
Over-the-counter (OTC) drugmaker, Barox Co., Ltd., was audited by the US Food and Drug Administration (FDA) between May 17-18, 2018.
On November 28, the FDA issued Barox a warning letter citing current good manufacturing practice (cGMP) violations observed on-site, including a lack of product labelling protocol.
Barox, which contracts a third-party manufacturer to make its OTC drugs, before relabelling the products for sale in the US, has “no written documents describing roles and responsibilities of a quality control unit (QCU),” wrote the FDA.
“All of your employees, including those in the QCU, lack knowledge of cGMP requirements,” added the agency.
In addition, the firm lacks strict control over its labelling operations, with no “proper…controls to prevent labelling mix ups,” the agency continued. “You failed to ensure that relabelling occurs under appropriate cGMP controls.”
Inspectors were also dissatisfied with Barox’s storage and warehouse protocol: “You have no procedures for storage and warehousing of drug products, including quarantine storage before release of drugs…Holding of drug product must be performed under appropriate cGMP controls.”
The agency ‘strongly recommends’ the firm engage an external consultant to address these concerns.
