Kay Mitchen

Auditor Nutrition and Wellness

About

Kay Mitchen has more than 30 years of regulatory experience in the FDA regulated industries. Her expertise is in the development and implementation of cGMPs and Quality System Standards applicable to the Drugs, In-Vitro Diagnostics Medical Devices, Cosmetics, Foods and Dietary Supplements industries. As officer for several companies, she successfully developed and maintained Quality System procedures to ensure overall GMP compliance with FDA, and achieve certifications to ISO, NSF and CE Mark among other international standards, as well as international products registrations, opening wide doors of business opportunities at the international level. She successfully hosted over 33 combined audits by the US FDA, Health-Canada, ISO, TUV Europe, NSF and Major clients and investors. She interfered with the US FDA and other State and Federal Agencies for the resolution of companies’ issues with a considerable history of successful problem solving experience. She also managed the development of programs for internal and suppliers’ audits and served as lead auditor for critical and technical areas and suppliers. Kay Mitchen is also the owner of FDA-GMP Consultants, a regulatory consulting firm. ----- With tens of years of successful interactions with regulatory agencies, FDA-GMP Consultants LLC can assist you with your cGMP (Good Manufacturing Practices) needs. Our strength is in GMP audits/gap analysis, and quality system development (SOPs), tailored to the nature of your operations. We work for the Dietary Supplement, Cosmetics, Medical Devices and Pharmaceutical industries. In other words, we are a global consulting firm organized to provide comprehensive Quality System and Compliance services for all FDA-regulated companies. FDA-GMP Consultants also networks with regulatory consulting firms, therefore offering you a one stop shop for all your regulatory compliance needs. Contact Kay, who offers the best regulatory compliance models at minimal costs.

Country

United States

City

North Port-Sarasota Area

Industry

Pharmaceuticals

Skill

Regulatory Affairs, Compliance Audits, Quality Management, Quality Auditing, Clinical Trials, CAPA, FDA, GMP, Quality System, Medical Devices, Quality Assurance, Technology Transfer, V&V, Change Control, Pharmaceutical Industry, ISO 13485, R&D, Validation, Regulatory Submissions, Regulatory Requirements

Experience

Auditor Nutrition and Wellness

NSF International

2025-10 - Present · 1 yr

Auditor - Regulatory Consultant - cGMPs Dietary Supplements

Third Party Accredited Regulatory Consultant

2015-9 - Present · 11 yrs 1 mo

Fort Lauderdale, Florida

Back-up to US Government Agency - Verification Program - cGMP Compliance - Dietary Supplements

Managing Director

dicentra

2013 - Present · 13 yrs

USA

Implementation of a quality system under section 21CFR210/211, tailored to sterile and non-sterile compounding operations. Development of SOPs and internal training.

Director of Regulatory Affairs and Quality

Sovereign Naturals

2006-11 - Present · 19 yrs 11 mos

United States

Director of Regulatory Affairs & Quality

Sovereign Naturals

2006-11 - 2015-9 · 8 yrs 11 mos

Pompano Beach, Florida

Implement operating and operational procedures and oversees to their suitability to meet international industry regulatory standards for dietary supplements, drugs, medical devices and cosmetics- Interact with international federal regulatory agencies and notified bodies in audits, products licensing and registration - ensure company's compliance to governing standards - deep involvement in human clinical trials, NIH certified.

Chief Compliance Officer

Sincerus Florida

2015 - 2025-10 · 10 yrs

Pompano Beach, Florida

Sets-up a quality system applicable to 503(B) facilities. Sincerus provides sterile and non-sterile pharmaceutical compounding services to physicians, group practices, surgery centers, and hospitals. We respect and fully comply with all local, national and international regulatory standards governing the manufacture of pharmaceuticals. On November 27, 2013, the Drug Quality and Security Act (DQSA) was made law. This legislation contains important provisions relating to the oversight of compounding of human drugs. Specifically, it outlines critical steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States. The FDA’s unprecedented level of oversight is intended to ensure drugs are compounded under CGMP and are ultimately in place to improve the quality and availability of drugs in the supply chain. We are committed to producing only the purest, safest, and most efficacious products possible, compromising nothing in the process.

Director of Quality Assurance

Health-Chem Diagnostics

2002-2 - 2006-11 · 4 yrs 10 mos

Successful implementation and maintenance of a quality system applicable to the manufacture and distribution of In-Vitro Diagnostics Medical Devices. Successfully achieved 510(k) registrations as well as ISO 13485-CMDCAS and CE mark.