The QMN Weekly Bulletin
Medical Devices / Regulatory Affairs / Inspections and Audits

Bausch + Lomb Lands 483 Over CAPA Procedures, Product Control

Dec. 6, 2013
A A
Bausch + Lomb Surgical was handed a Form 483 for issues related to its CAPA procedures and control of nonconforming product. The Clearwater, Fla., site failed to verify or validate several proposed CAPAs before implementation, including actions to prevent product mix-ups. The proposed actions were later found to be ineffective, the form notes.
The GMP Letter