We regularly represents 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. If you face inspection observations and/or warning letters, we craft responses and corrective action programs, and guide you through determining the scope of recall actions, implementing requisite recalls, and advise you on field corrections, retrofits, and supplemental labeling.
If you have more substantive FDA issues, we represent you in injunction actions and seizures, and litigate or negotiate consent degrees so you can continue or resume product distribution. Our attorneys believe in taking a proactive stance on your behalf. We also will help you avoid future enforcement problems by conducting regulatory and compliance audits for situations, general or discreet, about which you may have exposure concerns.
In addition, we also monitor compliance with FDA regulations relating 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.