Why are Regulatory Inspections So Critical?
Regulatory inspections are critical mechanisms for helping to ensure safe and effective, high-quality medicines are delivered to patients. This is the ultimate goal shared by medicine manufacturers and health authorities, such as the FDA.Manufacturers must take inspections extremely seriously.
Failure to prepare for inspections and create strong GMP habits every day could result in poor inspection results, including observations or 483’s which could escalate to a warning letter. In the case of severe or repeat violations this could result in injunctions, consent decrees, seizure of product or facilities, and even criminal prosecution. If violations are found during pre-approval inspections, inspectors may recommend that the FDA NOT approve a product for commercial manufacturing.
A firm’s reputation will be adversely impacted by warning letters and other regulatory consequences, which are a matter of public record. All of this can have major financial consequences, as well as the potential to not be able to make products for patients in need.
