FDA Cites Washington Device Firm for Device History Records

The FDA hit Personal Medical, a Redmond, Washington devicemaker for lacking information in its device history records.

The records did not include primary identification labels and unique device identifiers (UDIs) for every lot of product, the agency said.

Specifically, the firm did not have documentation for the primary identification labels and UDIs for lots of pessaries made by a contract manufacturer between January 2018 and June 2019.