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 –