Steve Brown
Former FDA Investigator · Regulatory Consultant · Alliance for Compounding Excellence
Steve Brown
Former FDA Investigator FDA Regulatory Consultant & Compliance AdvisorFDA Inspection Experience & Regulatory Readiness Expertise
Stephen Brown is a former U.S. Food and Drug Administration investigator with over 32 years of experience conducting inspections of pharmaceutical manufacturers, including 503A pharmacies and 503B outsourcing facilities.
During his FDA tenure, he led numerous inspections resulting in significant regulatory actions, including a corporate-wide injunction involving a multi-site 503B organization.
Today, Steve provides consulting services focused on risk-based audits, quality system assessments, and regulatory readiness. His work helps clients identify and remediate compliance gaps before FDA inspection.
His background gives ACE clients a practical inspection-focused perspective on the systems, documentation, and operational controls that matter when pharmaceutical facilities are preparing for regulatory scrutiny.
A Career Built Around
Inspection Readiness
Former U.S. FDA Investigator
Over 32 years of experience conducting inspections of pharmaceutical manufacturers and regulated operations.
503A Pharmacy & 503B Outsourcing Facility Inspections
Inspection experience includes both 503A pharmacies and 503B outsourcing facilities, giving clients practical insight into FDA expectations.
Significant Regulatory Action Experience
Led numerous inspections resulting in significant regulatory actions, including a corporate-wide injunction involving a multi-site 503B organization.
Risk-Based Audits & Quality System Assessments
Provides consulting services focused on risk-based audits, quality system assessments, and inspection readiness.
Regulatory Readiness Perspective for ACE Clients
Helps clients identify and remediate compliance gaps before FDA inspection, bringing an inspection-focused view to ACE certification support.
Inspection Knowledge &
Compliance Support
Ready to Begin
Certification?
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