FDA Warns Korean Drug Manufacturer
Posted 04 December 2018 | By
The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent 28 November to Korea-based Barox Co., Ltd. for significant violations of current good manufacturing practice (CGMP) regulations.
FDA said the firm relabels over-the-counter drug products manufactured by a contract manufacturer and then distributes the drugs to the US.
“You have no written documents describing roles and responsibilities of a Quality Control Unit (QCU). All of your employees, including those in the QCU, lack knowledge of CGMP requirements,” FDA said.
The warning letter also calls the company out for not having procedures for its relabeling operations, including the issuance and reconciliation of labels. The firm, which appears to distribute pain relief creams among other products, was also found to have no procedures for how it stores and warehouses drugs.
FDA recommends that Barox hire a consultant to assist it in meeting CGMP requirements.
“Drugs must be manufactured in conformance with CGMP. FDA is aware that many drug manufacturers use independent contractors, such as production facilities, testing laboratories, packagers, and labelers. FDA regards contractors as extensions of the manufacturer,” the letter adds. “You are responsible for the quality of drugs you produce, regardless of agreements in place with your contract facility.”
Barox Co., Ltd. 11/28/18