FDA enforcement actions

Executive Summary

Included forty-nine regulatory letters and 16 seizures during the first six months of 1990, Office of Compliance Deputy Director Sammie Young reported Sept. 18 in Bethesda, Md. Fourteen of the regulatory letters and eight of the seizures involved violations of Good Manufacturing Practices (GMPs). In all of 1989, 115 regulatory letters (including 48 concerning GMPs) were sent compared to 109 reg letters (35 for GMP violations) in 1988; and 106 (64 GMP) in 1987. There were 30 seizures (including 9 GMP violations) in 1989; 50 (9 GMP) in 1988; 50 (15 GMP) in 1987 and 83 (29 GMP) in 1986.