FDA 483 - Kelyniam Global, Inc. - July 22, 2021

Kelyniam Global, Inc., a medical device manufacturer in Collinsville, CT, was cited for significant deficiencies in its quality system during an FDA inspection. The observations primarily concern inadequate validation of cleaning processes for cranial and craniofacial implants, insufficient environmental controls, and widespread issues with device history records, document control, supplier management, and quality audits. These findings indicate a lack of robust quality management practices across several critical areas of device manufacturing.