FDA EIR - PureTek Corporation - December 15, 2017

An FDA inspection of PureTek Corporation, a drug and dietary supplement manufacturer in San Fernando, CA, took place from December 11 to 15, 2017. This comprehensive Current Good Manufacturing Practices (cGMP) drug inspection evaluated the company's Quality, Material, Facilities & Equipment, Packaging & Labeling, and Laboratory Systems. The inspection concluded with one significant observation documented on an FDA 483 form, citing a failure to properly clean and maintain equipment and utensils to prevent drug product contamination. Specifically, inspectors found a worn heat exhaust hose and a piece of cardboard taped near the tube exit of a filler machine, both presenting potential contamination risks. This finding directly referenced regulatory requirements under 21 CFR 211.67(a). PureTek Corporation's Senior Vice President of Quality & Technical Services acknowledged the observation and committed to implementing necessary corrective actions, including immediately replacing the deficient hose and cardboard with a stainless steel plate. A detailed written response outlining further preventative measures was required within 15 business days. The FDA informed management that failure to provide an adequate response could lead to further regulatory actions, such as a warning letter, seizure, or injunction. Notably, this inspection also verified that all 11 observations from a previous FDA inspection in March 2016 had been successfully addressed.