FDA 483 - Precision Biometrics, Inc. - December 21, 2021

An FDA inspection of Precision Biometrics, Inc. in Seattle, WA, conducted on December 20-21, 2021, identified a significant deficiency in the firm's document control procedures. Specifically, the company failed to adequately establish and implement its control of documents and records procedure, leading to software revisions being released for use before their required Document Change Order (DCO) approval dates. This indicates a breakdown in the firm's quality system regarding document management and software release protocols.