Managing suppliers is critical, and your processes in doing so must be documented.
Have repeat observations from a previous inspection? Expect a warning letter.
A well-balanced purchasing controls program encompasses many tools, but in an effort to meet the requirements delineated within §820.40, the FDA expects establishments to have certain elements in place.
A high degree of risk identification and management throughout the supply chain is what establishes a company as ‘world class,’ says Steve C de Baca – Senior VP, Global Quality & Regulatory, Beckman Coulter Diagnostics.