FDA 483 - Carwild Corporation - May 16, 2019

Caraid Corporation in New London, CT, a specification developer, was inspected by the FDA from May 13-16, 2019. The inspection revealed significant deficiencies in design control processes for their Ivalon PVA ophthalmic sponges. Specifically, the firm failed to review, update, and approve design plans as development evolved, and did not adequately establish procedures for design transfer.