Sanitary Inspections & Government Audits
Compliance is protection. Prevention is your best legal defense.
Health authorities in Mexico — primarily COFEPRIS and other sectoral regulators such as SAGARPA, CRE, and SEMARNAT — conduct Sanitary Inspections (Verificaciones Sanitarias) to ensure that companies engaged in the manufacture, import, storage, or commercialization of health-related products are in full regulatory compliance.
Pharmacounselors® provides comprehensive legal and regulatory support before, during, and after these inspections, minimizing risks and ensuring your operations meet all applicable sanitary requirements.
Our Sanitary Inspection Support Services include:
- Pre-inspection advisory and preventive audits to identify potential non-conformities.
- Preparation and submission of compliance documentation, manuals, and SOPs required by COFEPRIS.
- On-site legal and regulatory accompaniment during the inspection process.
- Representation in case of administrative findings, inspection reports, or official notices (Actas de Verificación).
- Development and execution of Corrective Action Plans (CAPA) in coordination with technical and quality teams.
- Defense in administrative sanction procedures, including appeals, rectifications, and hearings before COFEPRIS.
- Advisory on penalties and legal consequences arising from non-compliance, such as:
- Temporary or definitive suspension of operations
- Product seizure or destruction orders
- Fines and economic penalties
- License or permit revocation
- Criminal liability in severe cases of public health risk
Our multidisciplinary approach — combining regulatory professionals, quality auditors, and health-law attorneys — ensures that your company is always prepared to respond with confidence and compliance.
Objective:
To safeguard your company’s regulatory reputation, minimize operational risk, and maintain uninterrupted business continuity under Mexican sanitary law.
Tagline:
Compliance is protection. Prevention is your best legal defense.
PharmaCounselors® International 