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United States v. Bioclinical Systems, Inc.

United States District Court for the District of Maryland
666 F. Supp. 82 (1987)

Written by Mary Phelan D'Isa, JD

Facts

The Food and Drug Administration (FDA) brought an enforcement action under the Federal Food, Drug, and Cosmetic Act (FDCA) against Bioclinical Systems, Inc. (BSI) (defendant), the manufacturer of plated culture media. The FDA alleged that BSI failed to meet the FDA’s Good Manufacturing Practices, (GMPs)—as dictated by the FDA Office of Compliance—regarding a sterility assurance level (SAL) of 0.1 percent. BSI challenged the requirement, which had been adopted as the de facto standard ever since a draft set Inspection Guidelines incorporating the standard was issued by the FDA’s Center for Devices and Radiological Health.

Rule of Law

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Issue

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Holding and Reasoning (Motz, J.)

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A "yes" or "no" answer to the question framed in the issue section;
A summary of the majority or plurality opinion, using the CREAC method; and
The procedural disposition (e.g., reversed and remanded, affirmed, etc.).

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