PRINCIPAL CONSULTANT EXPERIENCES
- Independent Quality and Regulatory Auditor
- Mock FDA Inspections Consultant
- Former Supervisory Investigator, U.S. FDA Office Of Regulatory Affairs
- District Medical Devices Program Monitor
- International Inspection Cadre – Medical Device Group
- Compliance Officer, FDA Office Of Regulatory Affairs
- Investigator, FDA Office Of Regulatory Affairs
- Chemist, FDA Office Of Regulatory Affairs
- FDA Investigator Performance Auditor Certification
- FDA Investigator Certification
Our APC FDA Consultant served as a national expert in the laws and regulations that govern unapproved new drugs and dietary supplements. As a former FDA Compliance Officer, he reviewed and approved or disapproved Warning Letters, seizures, and injunctions. He has extensive knowledge in 21 USC when taking action against unsafe products in the U.S. market. Furthermore, he reviewed product labels and ensured that information is truthful and not misleading.
As a former FDA Investigator, our FDA consultant performed establishment inspections from the simple to the most complex type. In addition, he issued numerous FDA Form 483, Inspectional Observations, to the firms that were in violation of the FD&C Act and codes of the Code of Federal Regulations Title 21 (21 CFR) that require firms to adhere to Quality System Regulation (QSR). Also, he collected numerous documentary samples to establish FDA jurisdiction for required legal intervention by the FDA. Contact us to schedule mock FDA inspections by a former United States Food and Drug Administration Field Office Investigator.