FDA 483 - Dr. Joel Kaplan Inc. - June 30, 2023

An FDA inspection of Dr. Joel Kaplan Inc. in San Diego, CA, a specification developer of E.D. systems and light therapy wraps, revealed seven significant quality system deficiencies. The firm failed to establish fundamental procedures for complaint handling, design control, acceptance activities, supplier management, product identification, management review, and quality audits. These observations indicate a severe lack of basic quality system controls.