FDA 483 - ORTHO PRECISION PRODUCTS - November 14, 2023

An FDA inspection of ORTHO PRECISION PRODUCTS in Hawthorne, CA, from November 7-14, 2023, identified one observation related to inadequate maintenance of device history records. Specifically, several work orders were found to be missing critical in-process inspection results, dates, and initials. These issues were not addressed prior to lot release, despite internal quality work instructions.