FDA: Compliance & Enforcement

Our FDA compliance and enforcement practice spans the entire spectrum of our clients’ regulatory compliance interactions with the FDA—from the inspection to the courtroom. We represent drug, medical device, dietary supplement, and food clients in some of their most critical and sensitive dealings with the agency that controls every facet of their businesses. Because we respond to FDA inspection findings and related issues every day, we have a thorough understanding of the statutory and regulatory compliance issues our clients face. We have an insider’s insight into the perspectives and approaches of the FDA’s compliance officials and the DOJ attorneys who litigate enforcement actions for the FDA. We bring this knowledge and experience to bear in achieving evidence-based solutions for our clients.

Alston & Bird’s FDA enforcement team has been recognized by the American Health Lawyers Association, Chambers USA, and other ranking organizations as one of the nation’s top FDA regulatory law firms. We are also recognized in The Best Lawyers in America in both biotechnology and health care.

Our FDA compliance and enforcement team handles matters related to:

• Criminal investigations/litigation
• Civil investigations/litigation
• Consent decrees
• Seizures
• Import alerts
• Warning letters
• Untitled letters
• Regulatory meetings
• Data integrity investigations
• Form FDA 483 responses
• Inspection readiness
• Drug shortages
• Strategic counseling and support drafting comments on guidance documents
• Litigation support in product liability and commercial disputes related to manufacturing issues
• Due diligence reviews
• FSMA compliance counseling

• Provided strategic advice, counseling, and assistance for a comprehensive data integrity investigation, a warning letter, warning letter communications, risks associated with the warning letter, and the company’s decision to discontinue operations and decommission a manufacturing facility for a European client. 
• Assisted an overseas generic drug manufacturer (which produces more than 200 medications and active pharmaceutical ingredients) in responding to multiple requests for information related to FDA warning letters and import alerts. 
• Assisted a drug manufacturer in responding to the FDA’s inspection requests for highly technical information to demonstrate that the drug maker’s manufacturing process does not produce impurities. The FDA closed the inspection with no observations.
• Assisted foreign and domestic drug manufacturers with comprehensive data integrity investigations of analytical and manufacturing records held at their manufacturing facilities related to drug master files and product applications. 
• Prepared numerous senior management teams from global pharmaceutical and medical device clients for FDA regulatory meetings about the inspection classification of their manufacturing sites. We have also prepared written submissions requested by the FDA before these meetings.
• Advised a multinational company on CGMP requirements associated with registering as a drug establishment.
• Represented a dietary supplement manufacturer in a criminal and civil investigation into the potential distribution of adulterated and contaminated dietary supplements and drug products. The investigation was closed without any charges.
• Represented a medical device manufacturer before the DOJ Consumer Protection Branch and negotiated a nonprosecution agreement. 
• Represented medical device manufacturers at trial in two different FDA civil enforcement actions. The manufacturers prevailed in both cases.
• Represented a drug manufacturer in negotiating a consent decree and civil seizure action.
• Represented a compounding pharmacy in negotiating a consent decree.
• Represented a medical device company in an FDA civil seizure action.
• Represented two different food importers in litigation challenging FDA import alerts. Both cases were resolved when the FDA lifted the import alerts.
• Defended food manufacturers and transporters against claims of criminal violations of FDA regulations before the DOJ and a U.S. Attorney’s Office.
• Represented the quality assurance manager of a major food manufacturer in a criminal investigation by the DOJ and FDA into a nationwide salmonella outbreak.