SmartBrief
Confirm favorite deletion?
Administrative Law Keyed to Funk
John D. Copanos and Sons, Inc. v. Food and Drug Administration
Citation:
854 F.2d 510 (1988)Facts
From 1984 to 1987, the FDA conducted multiple inspections of Kanasco’s manufacturing facilities, repeatedly finding serious CGMP violations. These included falsified manufacturing records, unsanitary conditions, inadequately trained personnel, failure to validate manufacturing processes, and improper quality control procedures. After each inspection, the FDA provided Kanasco with a Form FDA-483 listing observed deficiencies. Despite Kanasco’s repeated promises to correct these problems, subsequent inspections continued to reveal similar violations. In 1984 and 1985, the government sought injunctive relief against Kanasco, resulting in agreements restricting the company’s manufacturing activities. In March 1987, the FDA published a Notice of Opportunity for Hearing proposing to withdraw Kanasco’s NDAs and NADAs for sterile injectable products. Kanasco requested a hearing and submitted declarations and exhibits purporting to show compliance with CGMP. Finding no genuine issue of material fact, the FDA denied the hearing request and summarily withdrew the approvals.
Only StudyBuddy Pro offers the complete Case Brief Anatomy*
Access the most important case brief elements for optimal case understanding.
*Case Brief Anatomy includes: Brief Prologue, Complete Case Brief, Brief Epilogue
- The Brief Prologue provides necessary case brief introductory information and includes:
Topic:
Identifies the topic of law and where this case fits within your course outline.Parties:
Identifies the cast of characters involved in the case.Procedural Posture & History:
Shares the case history with how lower courts have ruled on the matter.Case Key Terms, Acts, Doctrines, etc.:
A case specific Legal Term Dictionary.Case Doctrines, Acts, Statutes, Amendments and Treatises:
Identifies and Defines Legal Authority used in this case.
- The Case Brief is the complete case summarized and authored in the traditional Law School I.R.A.C. format. The Pro case brief includes:
Brief Facts:
A Synopsis of the Facts of the case.Rule of Law:
Identifies the Legal Principle the Court used in deciding the case.Facts:
What are the factual circumstances that gave rise to the civil or criminal case? What is the relationship of the Parties that are involved in the case.Issue(s):
Lists the Questions of Law that are raised by the Facts of the case.Holding:
Shares the Court's answer to the legal questions raised in the issue.Concurring / Dissenting Opinions:
Includes valuable concurring or dissenting opinions and their key points.Reasoning and Analysis:
Identifies the chain of argument(s) which led the judges to rule as they did.
- The Brief Prologue closes the case brief with important forward-looking discussion and includes:
Policy:
Identifies the Policy if any that has been established by the case.Court Direction:
Shares where the Court went from here for this case.