FDA 483 - Bausch & Lomb Incorporated - February 28, 2020

Bausch & Lomb Irvine, an API drug manufacturer in Irvine, CA, was cited for significant deficiencies in its quality system and laboratory controls. Observations included a lack of quality agreements with contract labs, unsupported API expiration dates, failure to follow QC procedures, and inadequate investigations into product discrepancies. The firm also had issues with its HPLC test procedures and chromatographic data review.