FDA 483 - Kelyniam Global, Inc. - August 15, 2019

An FDA inspection of Kelyniam Global, Inc., a medical device manufacturer in Collinsville, CT, revealed significant deficiencies in their quality system. Observations included a lack of established procedures for controlling environmental conditions during the manufacture and cleaning of cranial and craniofacial implants, inadequate procedures for the acceptance of incoming product, and insufficient validation of the cleaning process for implants.