483
IndeCon, Inc.FDA 483 - IndeCon, Inc. - December 12, 2024
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
Record Details
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.
Open in Dashboard
ID · ebd41097-1d7f-4af8-a96c-1e66f0ca86d3