FDA 483 - Bausch Health Americas, Inc. - April 12, 2024

Bausch Health Americas, Inc. in Petaluma, CA, a control testing laboratory, was cited for significant deficiencies in its Quality Control Unit's responsibilities and procedures. The inspection revealed failures to initiate investigations for audit trail deviations and equipment malfunctions, a lack of annual product reviews, and inadequate oversight of laboratory investigations and documentation. These issues indicate a systemic breakdown in quality assurance processes.