FDA 483 - Mindsight Medical Houston LLC - August 04, 2025

Mindsight Medical Houston LLC, a human tissue distributor in Spring, TX, received a Form FDA 483 with two observations. The inspection revealed deficiencies in maintaining documentation for equipment maintenance, cleaning, sanitization, and calibration of freezers used for storing frozen allograft human tissue products. Additionally, the firm's standard operating procedures for equipment maintenance were found to be inadequately defined.