FDA 483 - ProMed Pharma, LLC - October 17, 2023

An FDA inspection of ProMed Pharma, LLC in Plymouth, MN, a drug manufacturer, revealed a significant quality system deficiency. The firm failed to adhere to its own written procedures for conducting annual product reviews, which were established in a technical and quality agreement and detailed in an internal Standard Operating Procedure. This indicates a lapse in ensuring consistent product quality and compliance with regulatory expectations.