FDA 483 - Weeks & Leo Co Inc - March 29, 2018

Weeks & Leo Co Inc was cited for significant deficiencies in their manufacturing processes for dietary supplements. Observations included inadequate cleaning validations, lack of established specifications for incoming materials, and multiple failures in Master Manufacturing Records and Batch Production Records regarding controls, procedures, sampling, labeling, and record-keeping. Additionally, the firm lacked effective measures to prevent foreign material contamination, evidenced by a past complaint involving a metal screw.