FDA 483 - Kelyniam Global, Inc. - August 23, 2024

Kelyniam Global, Inc. in Collinsville, CT, was inspected regarding its manufacturing of Class II medical devices, specifically Cranial Implants. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate process validation for cleaning, poorly maintained device history records, and insufficient procedures for supplier control, training, and internal quality audits. These issues indicate a systemic lack of adherence to established quality system requirements.