FDA 483 - Integra CI Inc. dba Integra Neurosciences PR, Inc. - August 23, 2019

An FDA inspection of Integra CI Inc. dba Integra Neurosciences PR, Inc. in Anasco, PR, revealed five significant deficiencies in its quality system for medical device manufacturing. The firm failed to adequately establish procedures for corrective and preventive actions, design transfer, process validation, finished device acceptance, and purchasing controls. These issues are primarily related to problems with external cerebrospinal fluid drainage systems, including stopcock breakage and leaks.