Medical Co. To Correct Violations
WASHINGTON (APP) _ A major maker of blood-derived medicines agreed Tuesday to correct numerous manufacturing violations that potentially threatened patient safety.
In a consent decree filed in federal court, the Food and Drug Administration said Alpha Therapeutic Corp. of Los Angeles violated regulations that ensure the quality of treatments made from human blood plasma _ such as clotting factors taken by hemophiliacs and albumin used in burn victims.
The FDA said it knows of no illnesses related to Alpha Therapeutic plasma products.
But the FDA, during three inspections in 1996 and 1997, detected violations that could threaten public health, and said it went to court after Alpha Therapeutic failed to correct the problems. Violations included not adequately ensuring sterility, inadequate quality control and procedures to detect problems before medicines were shipped, and not maintaining proper records so doctors could quickly track recalled blood products.
In the consent decree signed Tuesday and filed in U.S. District Court in Los Angeles, Alpha Therapeutic agreed to a list of changes, including hiring an outside consultant to bring manufacturing into compliance with federal law.
``This is another instance of a step up in the increased surveillance and compliance by the FDA,″ said H. Edward Matveld, president and chief executive of Alpha Therapeutic. ``We are a leader in the industry and are always interested in high quality and safe products, and we are totally committed to working with the FDA on this issue.″