A consent decree is a legal agreement that is reached between a company and the FDA. It is a negotiated agreement detailing the voluntary actions pledged by the affected company to remedy nonconformances, including systems improvements, and to avoid FDA litigation. FDA uses consent decrees to change the overall corporate culture in compliance matters by pulling the company out of a pattern of long-standing current Good Manufacturing Practices problems and raising it to current standards. A consent decree commits the company to performing corrective actions in a timely manner, as verified by a third party.
Consent decrees are usually imposed as a result of continual non-conformance in a company’s quality management systems. Continual nonconformance is defined as repeated Form 483 observations transmitted to a company over the course of several audits and inspections. A repeated “Unsatisfactory” or “No Response” from a company to FDA warning letters also may be reasons for FDA action. A warning letter informs the company that FDA considers one or more products, practices, or processes to be in violation of the Food, Drug and Cosmetic Act.
FDA adopts the consent decree approach after the company has received repeated FDA 483s or warning letters concerning GMP observations and deficiencies, and these repeated offenses have not been corrected. Although the company and FDA have communicated and discussed the deficiencies, there may not be a clear definition of how the company has made progress to remedy chronic violations, or a clearly defined plan to get back on track. The consent decree ensures that the company will meet the required GMP guidelines. It allows the company to remain in business and ensures that the consumers continue to receive medications of reasonable quality.
« Back to Glossary Index