Manufacturers

Related Practices

Preparedness for an FDA inspection, assessing whether a customer complaint warrants a broader investigation or potential product recall, maintaining a quality system and ensuring ongoing staff compliance – even a small list of the things that cross your mind every day can be intimidating.  Not everyone appreciates that manufacturing an FDA-regulated product isn’t just assembly lines and widgets.  We get it because we’ve been helping product manufacturers for over 30 years.

We can help provide an independent perspective on your industry’s current good manufacturing practice (“cGMP”) standards.  We bring a practical and pragmatic approach to product manufacturing so that compliance with cGMPs can work seamlessly with your business’ ability to innovate and bring high quality products to market in a financially viable way.  All the while, we are looking for ways to assist your business in its mission to bring market-leading quality products to your customers and the American public.

Specifically, our attorneys can help you:

• Draft and negotiate Quality Agreements between you and your partners
• Assess the manufacturing quality compliance status of a potential acquisition
• Support internal audits of your facilities, processes, and procedures
• Prepare your management and staff for an FDA inspection
• Support your team during an FDA inspection
• Respond to FDA inspectional observations
• Design, implement, and communicate with FDA regarding remediation plans, including corrective and preventive action plans
• Defend your company in the event of a Warning Letter, Import Alert, or other FDA enforcement action
• Assist with developing elements of your quality system
• Conduct internal investigations if issues arise that require an independent look
• Assists in compliance with health care fraud and abuse laws and state and federal requirements relating to pricing, price reporting, and discounting