FDA 483 - The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories - March 06, 2020

The Harvard Drug Group, LLC, a corporate headquarters in Livonia, MI, was inspected and cited for significant deficiencies in its quality system. Observations included failures in drug product release testing and specifications, a dysfunctional quality control unit with inadequate procedures for supplier oversight, recall follow-up, and complaint handling, and a lack of readily available records. Additionally, the firm was found to have an insufficient number of qualified personnel for quality oversight.