Area of focus

Regulatory Inspections and cGMP

Handling an inspection is a critical event for your company. You want a team with strong relationships with FDA. You need support during inspections and the right response to the agency.

We help clients identify compliance risks early to prevent problems from happening. We can help you prepare for an FDA inspection or work ...

Representative experience

Provided onsite FDA inspection and GMP/data integrity support to manufacturing sites around the world, including in the United States, China, India, Japan, Europe, and South America.

Helped pharmaceutical companies, large and small, around the globe successfully resolve Form FDA 483 observations and Warning Letters.

Conducted privileged investigations of alleged significant GMP compliance and data integrity deviations.

Negotiated consent decrees on behalf of manufacturers and individual defendants.

Successfully assisted companies and individual defendants in vacating GMP consent decrees.

Provided regulatory and white collar investigation support to pharmaceutical companies in responding to qui tam (whistleblower) actions involving GMP and data integrity allegations.

Helped develop and implement GMP policies and procedures and related training.

Developed briefing materials and prepared CEOs and senior executives for “make or break” meetings with FDA.

Successfully counseled numerous foreign manufacturers through the process of lifting GMP Warning Letters and Import Alerts (Import Bans).

Negotiated civil and criminal settlements involving government investigations into GMP violations.

Developed responses and strategies to address drug approval issues and FDA complete response letters related to manufacturing and GMP concerns.

Engaged FDA on averting drug shortages due to manufacturing constraints.

Negotiated many GMP-related consent decrees with FDA, and defend criminal prosecutions of companies and executives under the Park doctrine.

Blog Post

FDA Shuts Down OTC Drug Manufacturer with Longstanding and Pervasive cGMP and Labeling Issues

On Tuesday, FDA announced the entry of a consent decree of permanent injunction against Keystone Laboratories, Inc. of Memphis, Tennessee for manufacturing OTC hair care and skin care...

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Hogan Lovells Publications

Fourth Circuit Holds That cGMP Deficiencies Alone Do Not Constitute a False Claims Act Violation Focus on Regulation

For several years now current good manufacturing practice (cGMP) violations have been viewed as "the next hot thing" in False Claims Act (FCA) litigation.

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