The so call “Barr Decision” is a decision of the United States District Court for the District of New Jersey delivered in 1993 by the Honourable Judge Alfred M. Wolin. The decision is a result of a civil case between the United States of America and Barr Laboratories Inc.
The FDA
The case is a result of allegations made by the United States Food and Drug Administration that Barr Laboratories had released adulterated drugs into interstate and international commerce because they had failed to comply with the requirements of current good manufacturing practice during their manufacture.
Deficiencies in Testing
The deficiencies for which Barr were cited were wide ranging and included deficiencies in testing and investigation. Although this decision only strictly applies in the USA, the instructor who has read the decision, believes that should a similar case come before the Courts of other jurisdictions the finding would be similar.
A review of the relevant findings is of value here as it provides clear in site of the legal requirements.