FDA 483 - Bausch & Lomb Incorporated - November 25, 2019

Bausch & Lomb Inc. in Rochester, NY, a control testing laboratory, received a Form 483 with two observations. The inspection revealed deficiencies in the quality control unit's document control process for laboratory worksheets, lacking proper issuance and audit trail. Additionally, the facility's sterility testing room was found to be in a poor state of repair, with missing ceiling tiles and rusted vents, indicating inadequate maintenance.