FDA 483 - W Manufacturing & Logistics, Inc. - December 16, 2019

An FDA inspection of W Manufacturing & Logistics, Inc. in Walnut, CA, conducted from December 11-16, 2019, revealed two significant issues. The firm failed to maintain backup files for electronic data from its FTIR system and did not perform routine equipment calibration according to a written program, specifically regarding the balance used for weighing bulk products. One of these observations was a repeat finding from a previous inspection.