United States v. Barr Laboratories, Inc.
United States District Court for the District of New Jersey
812 F. Supp. 458 (1993)

- Written by Alex Ruskell, JD
Facts
The Food and Drug Administration (FDA) and Barr Laboratories, Inc. (defendant) engaged in long-time litigation over Barr’s laboratory procedures. Specifically, the FDA believed that Barr violated current good manufacturing practices under the Food, Drug, and Cosmetic Act with Barr’s sampling strategy, retesting procedure, and reliance on averaging. Barr’s procedures were used in Barr’s day-to-day operations and in Barr’s standard operating procedures, and Barr employees vigorously defended them. Because of the threat of litigation, Barr changed some of its procedures, but not all. The FDA requested an injunction on Barr’s products.
Rule of Law
Issue
Holding and Reasoning (Wolin, J.)
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