FDA 483 - Knox Medical Diagnostics, Inc. - June 21, 2022

An FDA inspection of Knox Medical Diagnostics, Inc. in San Francisco, CA, revealed deficiencies in the firm's document control procedures. Specifically, test protocols for validating firmware and software changes to medical devices were used before their official release dates, indicating a failure to adequately implement established document and change control processes. This suggests a lapse in quality system compliance regarding document management.