FDA 483 - Weeks & Leo Co Inc - March 29, 2018
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · 053fd3e3-a4e1-4aea-965d-f712c7bb8c02