FDA 483 - LE PAPILLON LTD. - June 05, 2025

LE PAPILLON LTD., a contract packager in South Plainfield, NJ, was cited with three observations during an FDA inspection from May 21 to June 5, 2025. The firm failed to establish adequate production and process controls, including validation studies for OTC drug product filling and equipment cleaning. Additionally, the quality control unit's responsibilities were not fully followed, specifically regarding method verification and validation for both compendial and in-house test methods.