Inspections and Audits

Chinese Heparin Testing Lab Warned by FDA

A Chinese heparin contract testing lab has been warned by the FDA for significant cGMP violations, recalling unresolved questions and concerns from the Chinese heparin scandal a decade ago. Read More

PharmaTech Facility Cited by FDA

The FDA found numerous faults during inspections this year of the PharmaTech facility in Davie, Fla. — resulting in the agency issuing a Form 483 that described shortcomings in product-testing, packaging, labeling, and other procedures at the facility. Read More

FDA Cites ARJ Infusion Services Over GMPs

The FDA found substantial sterility problems on a visit to Kansas-based ARJ Infusion Services, makers of in-home intravenous medications for adults and children with rare and chronic conditions. Read More