John D. Copanos and Sons, Inc. v. Food and Drug Administration

854 F.2d 510 (1988)

From our private database of 46,100+ case briefs, written and edited by humans—never with AI.

John D. Copanos and Sons, Inc. v. Food and Drug Administration

United States Court of Appeals for the District of Columbia Circuit
854 F.2d 510 (1988)

  • Written by Susie Cowen, JD
Play video

Facts

John D. Copanos & Sons, Inc., and Kanasco, Ltd., affiliated enterprises owned by John D. Copanos (collectively, Kanasco) (defendant) produced sterile injectable drugs pursuant to a number of New Drug Applications (NDAs) and New Animal Drug Applications (NADAs) approved by the Food and Drug Administration (FDA). Under the Federal Food Drug and Cosmetic Act (FDCA), the FDA can withdraw prior approval of a drug on a number of statutory grounds. One such ground is a finding that the manufacturer’s methods, facilities, and controls were not adequate to assure and preserve the identity, strength, quality, and purity of the drugs as set forth in the agency’s Current Good Manufacturing Practice (CGMP) regulations. Over a three-year period, the FDA inspected Kanasco’s facilities on multiple occasions. The agency found numerous violations of the CGMP regulations during each of these inspections. The FDA issued a FDA-483 form after each inspection, detailing the nature of the Kanasco’s violations. Despite promises to come into compliance with FDA regulations, Kanasco failed to remedy its violations. It also violated agreements not to distribute its products until it was in compliance and kept false records to cover up various violations. The FDA eventually published a Notice of Opportunity for a Hearing (NOOH) in the Federal Register, in which the agency proposed to withdraw Kanasco’s NDAs and NADAs for sterile injectable products. The NOOH stated that if Kanasco wanted a hearing, it must present specific facts showing a genuine and substantial issue of fact that requires a hearing, and that if such information is not provided, the FDA could enter summary judgment against the manufacturer. In response to the NOOH, Kanasco requested a hearing and moved for summary judgment. Its hearing request included declarations and other exhibits designed to show that the company was in compliance with CGMP. The FDA denied Kanasco’s requests, and summarily withdrew its approval of the company’s applications. Kanasco petitioned for review of the FDA’s decision.

Rule of Law

Issue

Holding and Reasoning (Ginsburg, J.)

What to do next…

  1. Unlock this case brief with a free (no-commitment) trial membership of Quimbee.

    You’ll be in good company: Quimbee is one of the most widely used and trusted sites for law students, serving more than 747,000 law students since 2011. Some law schools—such as Yale, Berkeley, and Northwestern—even subscribe directly to Quimbee for all their law students.

    Unlock this case briefRead our student testimonials
  2. Learn more about Quimbee’s unique (and proven) approach to achieving great grades at law school.

    Quimbee is a company hell-bent on one thing: helping you get an “A” in every course you take in law school, so you can graduate at the top of your class and get a high-paying law job. We’re not just a study aid for law students; we’re the study aid for law students.

    Learn about our approachRead more about Quimbee

Here's why 747,000 law students have relied on our case briefs:

  • Written by law professors and practitioners, not other law students. 46,100 briefs, keyed to 987 casebooks. Top-notch customer support.
  • The right amount of information, includes the facts, issues, rule of law, holding and reasoning, and any concurrences and dissents.
  • Access in your classes, works on your mobile and tablet. Massive library of related video lessons and high quality multiple-choice questions.
  • Easy to use, uniform format for every case brief. Written in plain English, not in legalese. Our briefs summarize and simplify; they don’t just repeat the court’s language.

Access this case brief for FREE

With a 7-day free trial membership
Here's why 747,000 law students have relied on our case briefs:
  • Reliable - written by law professors and practitioners, not other law students
  • The right length and amount of information - includes the facts, issue, rule of law, holding and reasoning, and any concurrences and dissents
  • Access in your class - works on your mobile and tablet
  • 46,100 briefs - keyed to 987 casebooks
  • Uniform format for every case brief
  • Written in plain English - not in legalese and not just repeating the court's language
  • Massive library of related video lessons - and practice questions
  • Top-notch customer support

Access this case brief for FREE

With a 7-day free trial membership