FDA 483 - Atlantic Biologicals - January 14, 2020

Atlantic Biologicals Corps, an own label distributor and warehouse in Miami, FL, was inspected by the FDA. The inspection revealed significant deficiencies in the firm's quality control unit, including failures to maintain specifications, handle complaints, manage quarantined products, and ensure facility cleaning. Additionally, the firm failed to maintain calibration records for critical equipment, such as a refrigerator thermometer used for pharmaceutical products.