FDA 483 - MACLEAN-FOGG - May 22, 2025

MACLEAN-FOGG in Menomonee Falls, WI, a manufacturer of Class II Sharps Collection Containers, was cited for significant deficiencies during an FDA inspection. The firm failed to validate key manufacturing processes, including injection molding and assembly, and lacked established procedures for identifying valid statistical techniques and sampling plans. Additionally, the company's procedures for receiving and documenting product complaints were found to be inadequate.