HHS NEWS

U.S. Department of Health and Human Services


P98-4                           FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE           Print Media:       301-827-6242
January 27, 1998                
                                Consumer Hotline:  800-532-4440

ALPHA THERAPEUTIC CONSENT DECREE

Alpha Therapeutic Corp., a major manufacturer of products derived from human blood plasma, has agreed to bring its manufacturing standards into compliance with federal regulations under a consent decree with FDA and the Department of Justice to be filed today in the United States District Court in Los Angeles. The agreement follows several FDA inspections of the firm that documented extensive violations.

"This is an important action to help assure the safety and efficacy of products used by people with blood clotting disorders and diseases of the immune system," said Michael A. Friedman, M.D., FDA's Lead Deputy Commissioner.

"Medical products -- and especially those for patients with life-threatening diseases -- must be of the highest quality."

FDA investigators inspected the Los Angeles-based firm twice -- in April and in June-July 1996 -- and each time observed numerous deficiencies.

The firm responded by submitting corrective action plans to remedy the deficiencies.

However, a third inspection, conducted in February-June 1997, again documented numerous violations, many of which involved a failure to assure that critical production processes, equipment and systems performed reliably and with the required precision.

FDA inspectors also found deviations in the areas of employee training, computer security, record keeping, facilities, and investigations of product failure.

Under the terms of the consent decree, Alpha Therapeutic has agreed to hire an outside consultant who will assist the firm in ensuring that all production processes, facilities and controls are brought up to and remain in compliance with the public health laws and regulations.

Among other provisions, the firm has agreed to strengthen its quality assurance and control program; to assess its management controls and organizational structure to assure compliance with FDA requirements; to improve its internal audit system; and to improve its system of production and process controls.

Alpha Therapeutic has also agreed to improve its records management, including procedures for tracking returned products, and its reworking and reprocessing procedures.

The corrective actions, which will not adversely affect the availability of the firm's drugs and biological products, will be completed within specified timeframes and under the supervision of FDA and the court.

The consent decree is part of FDA's continuing surveillance to ensure the safety of products derived from human blood plasma.

####

ATTENTION TV BROADCASTERS: Please use open caption for the hearing impaired.