Diabetes Corp. Gets Warning Letter on Contamination Risks

Diabetes Corporation of America is drawing FDA scrutiny for problematic sterility practices that render their products adulterated.

The warning letter stems from an inspection of the company’s production facility in Franklin, Tenn., which revealed unsanitary conditions for prepared, packed and held drug products.

Investigators noted several deficiencies in the company’s sterility practices, such as the failure to establish hold times to ensure items remained sterile and no documentation verifying the sterility of multi-purpose solutions used in injectable drug products.