FDA Compliance Group LLC

Your solution to FDA compliance needs
FDA Compliance Group is located in Denver, Colorado

Management Team

FDA Compliance Group is led by principals Shelly Maifarth and Martina LaGrange, both of whom have worked for the U.S. Food and Drug Administration (FDA) and are experts in FDA compliance and FDA regulatory issues.

Shelly Maifarth

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.

Ms. Maifarth's expertise includes:

  • compliance assessments
  • quality control reviews
  • 483 and Warning Letter responses
  • 483 and Warning Letter remediation
  • labeling and website reviews
  • SOP development (Standard Operating Procedures)
  • S/AER (Serious / Adverse Event Reporting)
  • training on FDA requirements (laws and regulations)
  • FDA readiness training (preparing for an FDA inspection)
import / detention assistance (imports, foods, medical devices)
Martina LaGrange

Martina LaGrange

Ms. Martina LaGrange began her career in Seattle, as an FDA Field Investigator. In 1996, she moved back home to Denver, where she worked for the FDA for a total of 14 years as a Medical Device Specialist.

Ms. LaGrange performed medical device, dietary supplements, pharmaceutical / drug, and clinical investigator inspections in the United States and internationally. She has inspected some of the largest manufacturers in the world, with 75% of these inspections resulting in the issuance of an FDA warning letter. On several recommendations for injunction, she was the lead investigator.

Ms. LaGrange was a member of the FDA's Quality System Inspection Technique (QSIT) Reengineering Team. She assisted in creating a QSIT training CD-ROM and a QSIT CD exam. She also helped develop QSIT training for FDA managers and FDA compliance officers and was a presenter on the 7/00 LIVE video downlink that trained managers and compliance officers worldwide.

For her accomplishments in the medical device arena, Ms. LaGrange received Vice President Al Gore's Government Hammer Award.  She was also part of the Medical Device EIR (Establishment Inspection Report) workgroup, created to harmonize FDA inspection reports in accordance with the Mutual Recognition Agreement (MRA). Ms. LaGrange provided classroom training to FDA employees, European Union (EU) authorities, Colorado Department of Health and Environment workers, trade groups, and professional societies.

Since 2003, Ms. LaGrange has been an FDA consultant in the medical device, dietary supplements, pharmaceutical / drug, and clinical investigator areas. She continues to assist FDA-regulated companies in obtaining and maintaining compliance with FDA regulations.

Ms. LaGrange's expertise includes:

  • gap analysis
  • quality control reviews
  • mock FDA audits
  • 483 and Warning Letter responses
  • SOP development (Standard Operating Procedures)
  • MDR (Medical Device Reporting)
  • S/AER (Serious / Adverse Event Reporting)
  • training on FDA requirements (laws and regulations)
  • FDA readiness training (preparing for an FDA inspection)
  • compliance strategy planning