FDA 483 - RECKITT BENCKISER LLC - June 13, 2019

RECKITT BENCKISER LLC, a repackager in Saint Peters, MO, received a Form 483 for significant deficiencies observed during an FDA inspection. The firm failed to retain reserve samples for drug products and lacked adequate written procedures for handling labeling and packaging materials. Additionally, the quality control unit did not consistently follow its own procedures for deviation investigations, and production procedures were not documented at the time of performance.