FDA 483 - Weeks & Leo Co Inc - April 07, 2022

Weeks and Leo Inc., an OTC drug manufacturer in Clive, IA, received a Form FDA 483 with six observations following an inspection from April 4-7, 2022. The firm was cited for significant deficiencies in quality control, including inadequate investigations into discrepancies and complaints, lack of computer system controls, and failure to ensure drug product conformity to specifications. Other issues included insufficient scientific justification for water sampling and component testing, deficient complaint records, and a failure to establish appropriate time limits for production phases.