FDA 483 - OrthoSource Inc - January 26, 2023

OrthoSource, Inc. in Van Nuys, CA was inspected by the FDA from January 24-26, 2023, revealing significant deficiencies. The inspection found that the firm lacked adequate procedures for finished device acceptance, specifically regarding bond strength testing for adhesive products. Additionally, the company failed to establish routine calibration, inspection, and maintenance procedures for manufacturing equipment, with no corresponding records.