Atlantic Biologicals – FDA EIR, Jan 14, 2020

An FDA inspection of Atlantic Biologicals Corps in Miami, FL, was conducted from January 9-14, 2020. This initial inspection covered quality, materials, and facility/equipment systems of the drug product distributor and repackager. The inspection resulted in two main observations issued on an FDA-483 form. The primary issue was the absence of an effective quality control unit, cited under 21 CFR 211.22(a) (related to Current Good Manufacturing Practices for drug product quality control). This deficiency manifested in several areas: lack of documented specifications for refrigerated drug product storage, inadequate written procedures for handling medical complaints (including investigation and logging), and insufficient control over quarantined products, evidenced by no inventory log or proper identification. Additionally, the firm lacked written procedures and records for facility cleaning, despite a periodic regimen. The second observation, under 21 CFR 211.68(a) (related to equipment calibration), concerned the failure to maintain calibration records for equipment. Specifically, the thermometer in the refrigerator used for storing drug products was not calibrated, and maintenance activities lacked proper documentation. Ms. Karen L. Simmons, the owner, acknowledged the observations and committed to voluntary corrective actions. These include implementing temperature specifications for refrigeration, establishing a comprehensive complaint handling procedure, creating a controlled quarantine system with proper logging, developing and recording facility cleaning procedures, and initiating a calibration program for thermometers. A written response detailing these actions was promised within 15 business days. The FDA emphasized potential sanctions for uncorrected serious conditions.