Regulations

FDA Issues Warning Letter to Aqualex Over Sunscreen GMPs

The US FDA issues a Warning Letter to a Korean contract manufacturer.

The US Food and Drug Administration (FDA) issued a warning letter to Aqualex Co. Ltd., South Korea. According to FDA, Aqualex violated Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. FDA maintains the company’s methods, facilities or controls for manufacturing, processing, packing or holding do not conform to CGMP. As a result, the product is adulterated under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Furthermore, FDA noted that “DBH B...

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