FDA 483 - Abaco Partners, LLC - November 10, 2021

Abaco Partners, LLC, a manufacturer in Grand Rapids, MI, was cited for multiple significant deficiencies across its quality system, production, and laboratory operations during an FDA inspection. Key issues include inadequate quality control procedures, insufficient employee GMP training, and poor record-keeping for annual drug reviews and batch production. The firm also failed in microbiological and stability testing programs, including using an unregistered lab and not adhering to stability protocols.