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Shelly Maifarth

Shelly Maifarth

Principal, FDA consultant | Broomfield, Colorado    United States Of America
Public Health
FDA Compliance, Compliance Assessments,...More
Spoken at 3 events

Biography :

Ms. Shelly Maifarth began her 34-year career with the FDA as an investigator and microbiologist in the Dallas and Denver districts, holding these positions from 1972 to 1984. She then served as an FDA Compliance Officer in Denver's District office for more than 22 years. As an FDA Compliance Officer, she gained significant experience in the medical devices, dietary supplements, food, and pharmaceutical / drug areas. She has conducted FDA trainings, reviewed quality systems, and provided guidance on FDA quality, FDA labeling, and FDA compliance issues. Ms. Maifarth provided technical assistance and guidance to FDA investigators and analysts within the Denver District, as well as to local, state, and federal agencies, including CBP (Customs), EPA, and CDC. Since beginning her career as an FDA consultant, Ms. Maifarth has worked extensively with medical device and dietary supplement companies to assist them in achieving compliance with the requirements of FDA laws and regulations. On behalf of clients, she has coordinated meetings and successfully interacted with the FDA at the Denver District Office, FDA headquarters, and other district offices. She effectively coordinates all communications with the FDA post-audit, writes Form 483 and Warning Letter responses on behalf of clients, and coordinates subsequent follow-up.

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Public Health

Interested Topics

FDA Compliance, Compliance Assessments, Quality Control , Standard Operating Procedures, Adverse Event Reporting, FDA inspection, Detention assistance

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