When QMS Validation Goes Wrong: FDA Consequences

Before U.S. manufacturers can begin selling their products, they must ensure, by law, that their wares meet an acceptable level of quality.  A key part of that process is the act of providing objective, documented evidence to the U.S. Food and Drug Administration (FDA) that their processes, equipment and computerized systems are checked and validated.

Failure to meet these requirements can result in consequences of varying degrees of severity, depending on the nature of the offense and an outfit’s history with the FDA. These include:

  • Recommendation – Important feedback provided to companies with a good FDA relationship. An issue is noted in an audit file with the expectation that it be addressed by the next audit.
  • 483 form – A formal notice sent to the head of a company’s Quality department, with a response due within 30 days. This a low-key public record similar to a misdemeanor.
  • Warning letter – A public letter sent to a company’s CEO with a plan due within 30 days. This is similar to a felony offense and may result in a second and third warning letter.
  • Consent Decree – This is a legal action taken by the FDA through the U.S. courts and is similar to a warning letter. An overseer who reviews a Quality remediation can be involved in more complex cases. The results of a Consent Decree can be severe: fines, shutting down of portions of an operation, or suspension of licenses. An infrequent Consent Decree issued by the FDA raises industry awareness of the seriousness of a particular offense. Because this action constitutes an actual lawsuit and is played out in the U.S. court system, the spotlight is particularly bright on the recipient. Some cases have taken years to play out.

Learn more about QMS validation and the benefits of using cloud computing technology to achieve it in Intelex’s Definitive Guide to Validating Your QMS in the Cloud.


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