JAD Regulatory Consulting Inc.
U.S. FOOD & DRUG ADMINISTRATION CONSULTANT SERVICES
Jad Regulatory Consulting Inc. invites you to take advantage of our no-nonsense hands on approach to achieving compliance with U.S. FDA regulations and requirements. Our experienced staff is ready to assist you to become compliant with the FDA regulations. We are Subject Matter Experts on FDA Compliance. Our Consultants can help your establishment achieve FDA or GFSI-Approved Certification.
Jad Regulatory Consulting Inc. has strong knowledge of the laws and regulations associated with an inspection and enforcement program for the United States Food and Drug Administration. We are Particularly effective providing consulting services dealing with your concerns.
Our mission is to assist Foreign & Domestic, manufacturers and producers in developing and implementing cost-effective regulatory and business strategies to meet U.S. FDA regulations and requirements for their specific products.
Compliance with U.S. FDA regulations is the surest way to dramatically increase the value of your products and to expand to the global market. However, the FDA can also cause serious financial consequences as well as potential irrevocable damages to Syour corporate image. The FDA has a strict screening process and FSMA is the new law and the FDA can suspend any company’s registration and prevent them from importing their products to the U.S.A.
The ownership is held by Judah Vincent Duncan, formerly (legal name change) Vincent Duncan. Mr. Duncan is a former 18 years FDA Senior Investigator. While with the Food and Drug Administration, the founder has performed numerous inspections and investigations of food establishments.
Other accomplishments include:
- Performed inspections that lead to over 12 Warning Letters.
- Certified by the GMP Institute as a GMP Auditor in Quality Systems.
- Training in Prior Notice of Imported Goods & Food firm registration.
- Completed all FDA advanced training courses for certification.
- Led the most complex inspections and identified as “Lead” investigator on team inspections.
- Received over 14 performance awards including a Letter of Recognition from the FDA Commissioner.
- Received performance award for completing over 90% of all downstate (NYC) HACCP inspections, which resulted in the firm’s first untitled warning letters.
- Trained junior Investigators on HACCP inspections and special investigations.
- Completed 120 days detail at the FDA Prior Notice Center/Public Health Security Act and Bioterrorism Preparedness and Response Act.
- Performed work with Import Alert, refusal and detention request.
- Perform entry review on all FDA regulated products.
- First certified Investigator in New York District/Imports operation Branch.
- First investigator on HACCP certification program.
- Level One Certification as an FDA Investigator, is part of the special FDA certification program.
Professional positions held:
- Quality Assurance Director
- Quality Assurance Manager
- Sanitation Manager
Relevant Food Safety Certification:
- SQF lead auditor in high risk, achieving 20 sectors.
- BRC lead auditor.
- Certified GMP Quality Auditor
- Lead auditor Certification in FSSC22000 requirements, ISO 22000:2005
- PCQI Lead instructor under FSMA.
- Three HACCP certification, which includes seafood HACCP certification.
Relevant FDA Courses Attended and Successfully Completed:
- A01 Food and Drug Law: FDA Jurisdictions
- Food and Drug Law: FDA Jurisdictions (FDA01D)
- Food and Drug Law: FDA Jurisdictions (FDA01E)
- Food and Drug Law: FDA Jurisdictions (FDA01O)
- FDA02 Food and Drug Law: Prohibited Actions
- FDA organoleptic analysis course
- Food and Drug Law: Prohibited Actions (FDA02D)
- FDA03 Food and Drug Law: Judicial Actions
- Food and Drug Law: Judicial Actions (FDA03D)
- FDA04 Food and Drug Law: Criminal Acts Violations
- Food and Drug Law: Criminal Acts Violations (FDA04D)
- FDA05 Food and Drug Law: Imports and Exports
- FDA37 Import Operations 1: Background
- FDA42 Import Operations 2: The Process
- FDA56 An Introduction to the Public Health Security and Bioterrorism
- Food Microbiological Control
- Certified by the GMP Institute as a GMP Auditor in Quality Systems
- Import Enforcement Training Course
- Acidified/Lacf Food Import Course
- Step-by-Step Approach to Process Validation
- Food Law for State Regulators and Import Operations
- Import Operations and Entry Review/Import Enforcement
- Public Health Security and Bioterrorism Preparedness and Response Act
- Certified GMP Quality Auditor
The founder has received such honors and awards as:
- FDA’s Commissioner’s Special Citation (Highest award given to any employee)
- Harvey Wiley Medal (Highest award given to any employee)
- 9-11 Emergency team response citation.
- HHS Investigator General Integrity Award.
- Office of Regulatory Affairs Special recognition award.