GMPs

Maryland Drugmaker Warned on Sterility

Sterility concerns and other deficiencies at a Maryland drugmaker could be putting patients at risk, the FDA told Option Care Enterprises in Columbia, Md. in a July 20 warning letter. Read More

Drugmaker Cited for GMP, Quality Issues

A PET finished dose manufacturer in Ohio was cited by the FDA after investigators witnessed numerous cGMP violations and potential quality problems on a January 2014 site visit. Read More