Importance of Inspections

Why are inspections so important? As stated previously, they are a critical mechanism for helping to ensure safe and effective, high quality medicines for patients, which is the ultimate goal shared by medicine manufacturers and health authorities, such as FDA.

Manufacturers must take inspections extremely seriously. Failure to prepare for inspections and create strong cGMP habits every day could result in poor inspection results, including observations (or 483’s, noted on FDA’s Form 483), warning letters. In the case of severe or repeat violations 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.

Poor Inspection History= More Inspections

Firms with a poor inspection history also incur more inspections, as they are considered higher risk by health authorities, who use a risk-based approach in determining their inspection schedule. Additionally, 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.