FDA 483 - MD Logistics, LLC - March 04, 2022

MD Logistics, LLC, a repackager in Plainfield, IN, was cited for significant quality system deficiencies during an FDA inspection. Observations included a failure to thoroughly investigate recurring nonconforming quality problems, such as missing lot numbers, and a lack of effective corrective and preventive actions. Additionally, the firm's complaint handling procedures were found to be deficient, with sales representative reports often misclassified as deviations instead of customer complaints.