FDA 483 - Concord, Inc. dba Carlton's Dunwoody Pharmacy - April 12, 2019

During an inspection conducted from April 8 to April 12, 2019, the U.S. Food and Drug Administration (FDA) identified significant deficiencies at Concord, Inc. dba Carlton's Dunwoody Pharmacy, a facility specializing in the production of non-sterile drug products. The primary issue cited in the FDA 483 document involved the inadequate cleaning of work surfaces and utensils used in the manufacturing of highly potent drugs. Specifically, inspectors observed that the company's cleaning procedures failed to incorporate a cleaning agent effective in deactivating hormonal drug products. This deficiency raises concerns about potential cross-contamination, which could affect the safety and quality of their drug products. These observations underscore a deviation from regulatory expectations, particularly regarding Good Manufacturing Practices (GMP). To resolve this, Carlton's Dunwoody Pharmacy is required to implement comprehensive corrective actions, including a thorough revision of its cleaning protocols to ensure the prevention of cross-contamination by integrating appropriate deactivating agents for potent drug residues. Such actions are essential for ensuring product integrity and maintaining regulatory compliance.