FDA 483 - Jajco, Inc. DBA Anchor Drugs Pharmacy - October 29, 2018

During an inspection conducted by the U.S. Food and Drug Administration (FDA) from October 24 to October 29, 2018, Jajco, Inc. operating as Anchor Drugs Pharmacy, a producer of non-sterile drug products, received a Form FDA 483. This document outlined significant observations regarding the firm’s manufacturing practices, indicating deviations from expected quality standards. The primary concerns revolved around inadequate cleaning procedures and contamination control. Specifically, the FDA noted that Jajco, Inc. produced hazardous drugs, such as testosterone and estradiol, without ensuring proper cleaning of work surfaces and utensils. The firm utilized non-dedicated equipment cleaned with common household detergents and wipes, a process deemed insufficient to prevent potential cross-contamination between different drug substances. This poses a risk to patient safety by potentially mixing active pharmaceutical ingredients. Furthermore, investigators observed non-microbial contamination, characterized by powder residue buildup, in a production hood used for compounding various non-sterile human, animal, and hazardous drugs. Critical areas within this equipment were not included in the firm's routine cleaning operations, exacerbating the risk of product contamination. The FDA 483 signifies that Jajco, Inc. must promptly address these deficiencies by developing and implementing comprehensive corrective and preventive actions. These actions are crucial to ensure compliance with good manufacturing practices, safeguard product quality, and prevent adulteration of drug products.