We regularly represent clients in FDA compliance and enforcement matters. We are equipped to deal with FDA headquarters' compliance offices and the regional, district, and resident field offices. Our FDA attorneys counsel clients during the FDA inspection process. When inspection observations and/or warning letters are required, we help craft responses and corrective action programs. We aid companies in determining the scope of any necessary recall actions, implement requisite recalls, and advise on field corrections, retrofits, and supplemental labeling.

During more substantive FDA regulatory compliance and enforcement matters, we represent clients in injunction actions and seizures, and litigate or negotiate consent degrees so they can continue or resume product distribution. In addition to helping clients respond to FDA compliance emergencies, we can help them avoid enforcement problems by conducting regulatory and data-integrity audits focused on general circumstances or discrete situations in which a client may be concerned about possible exposure.

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