FDA 483 - Menasha Packaging Company, LLC - November 06, 2025

Menasha Packaging Company, LLC in Lititz, PA, a repacker/relabeler, was cited for two significant observations during an FDA inspection. The firm failed to conduct Annual Product Reviews for drug products and lacked a procedure for them. Additionally, the company did not follow its own change control procedures for the relocation of equipment used in repackaging drug products.