FDA Fines American Red Cross for Blood Safety Violations

Jan 31, 2012   

After conducting inspections of American Red Cross facilities between April 2010 and October 2010, the FDA found that 16 blood collection sites did not meet the FDAs standards for safety. These “significant violations” included inadequate managerial control, record-keeping and quality assurance. According to the FDA, however, the lapses did not lead to serious health consequences for blood recipients. The Red Cross has announced that it has taken corrective action to address the FDAs concerns. On January 18, 2012, the U.S. Food and Drug Administration (FDA) fined the American Red Cross $9.59 million for failing to comply with blood safety regulations.

The FDA, through the Center for Biologics Evaluation and Research (CBER) and Office of Regulatory Affairs (ORA), is responsible for the regulation of the collection of blood and blood components used for transfusion or for the manufacture of pharmaceuticals derived from blood and blood components.  Pursuant to Section 351 of the Public Health Service Act (“PHS Act”) and the Food, Drug, and Cosmetic Act (“FDCA”), the FDA oversees and enforces quality standards, conducts inspections of blood establishments, and monitors reports of errors, accidents and adverse clinical events.

The FDA inspects blood establishments to ensure that products are manufactured safely and in a way that protects the purity, potency and quality of the blood products. In addition, the FDA requires blood establishments to properly screen donors, maintain good manufacturing practices (cGMPs), maintain accurate records, investigate any breaches of establishment safeguards, and correct system deficiencies. Licensed blood facilities may engage in the sale, transport, and exchange of blood and blood products across state lines.

Failure to comport with the FDAs regulations may result in enforcement action in the form of a fine, as in the Red Crosss case, regulatory action letters, or revocation of establishment licensure.  In previous years, the FDA has entered into Consent Decrees with several blood bank establishments, such as the American Red Cross and the New York Blood Center, for violations of cGMPs and inadequate quality assurance programs. The FDA has also suspended the license of a blood center (Intermountain Health Care) due to numerous cGMP violations. Although the FDA has expressed its continued commitment to upholding high standards for blood collection and blood bank establishments, the onus of compliance with the FDAs regulations and the safety of the nations blood supply rest in the hands of the individual blood establishments.

Fuerst Ittleman will continue to monitor the FDAs regulation of biologics products and establishments. For more information, please contact us at contact@fidjlaw.com