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The agency issued over 300 Regulatory Letters to establishments in 1974—mostly to blood facilities. These official letters identify violations and indicate a deadline for correction before the party is subject to court proceedings. The Bureau of Biologics also obtained a decree for the destruction of improperly stored lots of influenza vaccine and tetanus toxoid and secured a permanent injunction against multiple facilities of a Florida plasmapheresis firm in major and repetitive violation of regulations for the collection and processing of plasma. Two years later FDA obtained the first permanent injunction against an intrastate blood bank, which enjoined it from operating in violation of the Federal Food, Drug, and Cosmetic Act. Inspections at an Ohio hospital blood bank on two occasions revealed serious deficiencies which threatened both blood donors and recipients, and each visit prompted increasingly severe warnings if non-compliance with regulations continued. After a third inspection revealed ongoing and hazardous operations outside of the regulations, the agency secured the permanent injunction, which allowed the hospital to operate only in emergency situations and to receive blood from outside sources.
Adverse event reporting has had a checkered history across all FDA medical product centers. In October 1994, CBER amended the biologics regulations to require that manufacturers of licensed biological products must report to FDA, within 15 working days, all serious and unexpected adverse events relating to their products; any significant increase in the frequency of serious but expected reactions; periodically, all other adverse experiences; and biologic distribution information.
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