The FDA warned a manufacturer of skin-care drug products in The Philippines for significant GMP violations.
In a Jan. 30-Feb. 1 inspection of Skin Sciences Laboratory, the investigator found the facility had failed to analyze glycerin raw material from the supplier to detect diethylene glycol (DEG) prior to releasing the glycerin for use in drug manufacturing. DEG has been linked to fatal poisoning incidents worldwide. The ingredient is used in multiple drug products manufactured in the facility.
Skin Sciences Laboratory also failed to test products for identity and strength of active ingredients prior to release and distribution, the FDA said, in a warning letter.
In addition, the company made drug claims for an antiperspirant product, making it an unapproved new drug, the agency said.