FDA WARNING_LETTER - Bracco Diagnostics, Inc. - July 11, 2011

The FDA issued a Warning Letter to Bracco Diagnostics Inc. following a June 23 to July 11, 2011, inspection, identifying significant Current Good Manufacturing Practice (CGMP) violations for Finished Pharmaceuticals (21 CFR Parts 210 and 211). These violations render their drug products adulterated under 21 U.S.C. § 351(a)(2)(B).

A primary violation cited was the failure to thoroughly investigate batch failures (21 CFR § 211.192). Specifically, the firm did not adequately investigate numerous customer complaints regarding cracked vials of Iopamidol Injection 76% (Isovue-370), which compromises sterility and poses a serious patient hazard. While Bracco Diagnostics hired a third-party consultant, a root cause was not identified, and no risk assessment for distributed product was provided.

The inspection was also initiated due to unexpected radiation exposure reports from CardioGen-82® (Rubidium Rb 82 generator) PET scans. The FDA acknowledged the firm's commitment to corrective actions for CardioGen-82®.

Overall, the FDA expressed concern about the firm's fundamental understanding of quality assurance and regulatory expectations, emphasizing the need for an effective quality system and management's leadership in quality throughout the company, including with contract manufacturers and imaging facilities. Bracco Diagnostics is ultimately responsible for product quality regardless of manufacturing agreements.