FDA 483 - Next Step Medical Co Inc - March 28, 2019

An FDA inspection of NEXT STEP MEDICAL in Rio Piedras, PR, a human tissue establishment, identified two significant observations. The firm failed to properly record and maintain storage temperatures for musculoskeletal human tissue products and maintained incomplete receiving records that did not identify the person performing incoming tissue inspections. These issues indicate deficiencies in record-keeping practices for human cells, tissues, and cellular and tissue-based products (HCT/Ps).