Pérez Correa González has advised a global company in connection with an FDA inspection in Mexico, supporting the client throughout the preparation, coordination and management of the process.
The inspection has now concluded without the issuance of written observations or an FDA Form 483 at close-out. The outcome followed extensive preparatory work and a coordinated legal and operational strategy designed to manage the inspection process, information flow and on-site response protocol.
PCG advised on the legal and strategic aspects of the inspection, including preparation protocols, communication channels, document handling and response coordination during the process.
The matter was led by our partners, Luis González and Omar Aguilar.
