FDA 483 - Ruspak Corporation - September 13, 2019

Rusnak Corporation, Inc., a repacker in Lyons, NY, was cited for three significant observations during an FDA inspection. The firm failed to adequately investigate a foreign body found in bulk drug product, maintained unclean equipment used for OTC drugs, and did not review unexplained discrepancies in batch records. These issues collectively pose risks of contamination and mislabeling for their drug products.