Peter V. Lindsay is a partner in the Investigations and White Collar Defense practice, based in the firm’s Washington D.C. office.
Mr. Lindsay focuses his practice on advising clients regarding a range of FDA regulatory, compliance, and enforcement issues, including those related to manufacturing (cGMPs/QSR) and other post-approval requirements. He has conducted significant internal reviews for life science companies addressing promotional activities, supplier management and supply chain risks, manufacturing activities, and safety reporting. His practice also spans crisis management strategy and helping companies address recalls and other significant market actions. He has advised companies in government investigations involving criminal and civil issues regarding alleged violations of the federal Food, Drug, and Cosmetic Act, the federal Anti-Kickback Statute, and the federal False Claims Act.
Mr. Lindsay has defended many clients across the FDA-regulated product spectrum, including medical devices, pharmaceutical manufacturers (API and drug product), and biotech companies. This support includes advising companies on many aspects of FDA regulatory and enforcement actions related to manufacturing quality inspections, warning letters, recalls, seizures/injunctions, and consent decrees. He also supports corporate transactions by conducting regulatory due diligence on FDA-related matters.
GMP/Quality System Regulation (QSR) Enforcement and Compliance
Regulatory and Enforcement Counseling
Paul Hastings Named to World’s Top 10 Best Investigations Practices by Global Investigations Review
October 23, 2020
Paul Hastings Launches FDA Regulatory Practice with Leading FDA Enforcement and Investigations Duo
August 05, 2020
FDA Manufacturing Challenges for Gene and Cell Therapy Developers
October 19, 2020
Carpe Diem: A Holistic Strategy for Assessing Supply Chain Compliance Risk in a COVID-19 World
September 28, 2020