FDA 483 - IndeCon, Inc. - December 12, 2024

An FDA inspection of IndeCon, Inc. in Dallas, TX, an HCT/P distributor, revealed significant deficiencies in record-keeping practices. Observations included failures to concurrently document incoming product evaluations, record HCT/P storage temperatures, and retain HCT/P-related records for the required duration. These issues indicate a lack of adequate control over critical operational and quality processes.