FDA Regulatory Compliance and Enforcement

We regularly represent businesses in FDA compliance and enforcement matters, and are equipped to deal with FDA headquarters’ compliance offices and the regional, district, and resident field offices. Our FDA Regulatory attorneys will guide you through the FDA inspection process. When inspection observations and/or warning letters are issued, we help craft responses and corrective action programs. We can determine the scope of any necessary recall actions, implement requisite recalls, and advise you on field corrections, product modifications, and supplemental labeling, as needed.

If your FDA regulatory compliance and enforcement matters are more complex, we can assist in injunction actions and seizures, and litigate or negotiate consent decrees so you can continue or resume product distribution. In addition to FDA compliance emergencies, we can help you avoid enforcement problems by conducting regulatory and data-integrity audits focused on general circumstances or discrete situations in which you may have potential exposure concerns.

Additionally, we monitor compliance with FDA regulations promulgated pursuant to the Bioterrorism Act, including facility registration, prior notice of imported food and beverage shipments, and records maintenance and inspection; with FDA Hazard Analysis and Critical Control Points programs; and with import/export procedures.