FDA 483 - Protek Medical Products Inc - August 08, 2019

Protek Medical Products, Inc. in Coralville, IA, was cited with three observations on a Form FDA 483. The inspection revealed deficiencies in establishing adequate procedures for process changes, ensuring purchased products and services conform to requirements, and timely transmission of medical device reports to the FDA. These issues highlight a need for improved quality system controls in manufacturing process validation, supplier management, and regulatory reporting.