FDA 483 - Cross Brands Contract Filling, LLC - July 19, 2021

Cross Brands Contract Filling, LLC, an OTC drug manufacturer in West Melbourne, FL, received a Form 483 citing significant deficiencies across its quality, laboratory, facilities, and production systems. Observations included failures to investigate microbial contamination, inadequate quality control oversight, insufficient laboratory controls for product testing and stability, and unvalidated cleaning and manufacturing processes. These issues indicate a severe lack of adherence to CGMP requirements.