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Who We Are

The Office of Manufacturing Quality (OMQ) evaluates compliance with manufacturing requirements for drugs based on inspection reports and evidence gathered by FDA investigators. OMQ develops and implements compliance policy and takes risk-based actions to protect the public from adulterated drugs in the U.S. market.

What We Do

• Develop and implement compliance and enforcement policies and actions to protect patients from products that are produced under conditions that may pose a risk to public health.
• Work to bring inspected facilities with significant violations of federal laws and regulations into compliance through warning letters and other actions.
• Collaborate with FDA investigators to ensure the uniform application of risk-based, patient-focused compliance and enforcement policies and actions.
• Evaluate manufacturing and product quality issues to mitigate and prevent drug shortages.

Organization

• Division of Drug Quality I
• Division of Drug Quality II
• Manufacturing Quality Guidance and Policy Staff

Contact Us

Email: [email protected] 

Phone: 240-402-0990

Office of Compliance
10903 New Hampshire Avenue
Bldg. 51, Room 4337
Silver Spring, MD 20993-0002 

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