The FDA slapped Phoenix-based outsourcing facility Atlas Pharmaceuticals with a warning letter for adulterated and misbranded drug products as well as numerous CGMP violations stemming from an inspection carried out in August and September 2017.
The FDA investigator noted that some of the drug products the facility produced were not properly labeled. Some failed to include the statement “not for resale” on their labels, while others were labeled as “compounded preparations” instead of “compounded drugs.”
The agency also found that the firm’s drug products — which were expected to be sterile — were adulterated as they had been exposed to conditions that may have led to contamination. For example, the firm neglected to disinfect equipment and supplies after moving them from low to high quality areas. Specifically, the inspector saw an employee “transporting materials used in sterile drug production from an ISO-8 classified room to an ISO-7 classified room without disinfecting the materials.”