FDA 483 - Contacare Ophthalmics & Diagnostics - November 01, 2018

Contacare Ophthalmics & Diagnostics, a sterile drug manufacturer in Dabhasa, India, was cited for significant deficiencies in its aseptic processing, environmental monitoring, and quality control systems. The inspection revealed failures in personnel monitoring, media fills, sterility testing investigations, cleaning procedures, and validation of sterilization processes. Additionally, issues with complaint handling, documentation practices, and computer system controls indicate a broad lack of adherence to cGMP requirements, posing a high risk to product sterility and data integrity.