An import alert is imposed when a pharmaceutical product or manufacturer is found to violate regulatory standards. Common reasons include:
- Poor manufacturing practices (GMP violations)
- Contamination or adulteration of products
- Mislabeling or false advertising
- Failure to comply with regulatory filings and requirements.
Once an import alert is issued, the affected products are detained at the border and cannot enter the market until the issues are resolved. This can lead to significant financial and reputational damage for the manufacturer.
MASUU helps in lifting the import alert, by proposing corrective actions, which may include:
- Improving manufacturing processes to comply with Good Manufacturing Practices (GMP)
- Conducting thorough investigations to identify and correct the root causes of the violations.
- Implementing robust quality control measures
- Engaging in third-party audits and inspections
- Providing detailed documentation and evidence of compliance to the regulatory authority.
The regulatory authority reviews the corrective actions taken by the manufacturer. This can involve inspections, reviewing documentation, and sometimes re-sampling and wwwing of products.