Message From the President
Dusty Snoeberg-Renwick
Greetings! I am Dusty Snoeberg-Renwick, a former FDA Pharmaceutical and Medical Device Investigator. I established XFDA Investigators, LLC in 2004 to help clients like you pass FDA audits and comply with the required federal regulations. cGMP /QSIT/GCP requirements are not hard to adhere to when the right procedures and systems are implemented. However, when I was an Investigator with FDA, performing PAI/cGMP/QSIT and GCP inspections, it was counterproductive trying to inspect quality systems that were impossible to follow, due to the unnecessary and over-demanding requirements that had been proceduralized in SOPs, protocols, etc. This happens when people don't understand exactly what is required by FDA regulations or an inspection authority. They go extremely overboard with demands that are too cumbersome to perform and very difficult follow. My colleagues and I agree, this made our FDA Investigators job very tough!
What is most concerning to me is that firms pay various consultants millions of dollars and trust them to help implement quality systems that will pass FDA scrutiny. However, these same firms are receiving significant observations, warning letters (OAI) or worse from their FDA inspection.
My Team of consultants are experts in their specific areas, and know what FDA expects from a solid quality system. We have helped firms set up quality systems that received no FD-483’s from the FDA during their PAI inspections; remediated both overly complex or substandard quality systems, due to an unsuccessful FDA inspection; and authored warning letter and/or FD-483 responses that were completely accepted by the Agency with the first response.
I promise if you hire my Team of XFDA Investigators, Compliance Officers and Industry Experts, we will work hard with your team to implement a sustainable quality system that is compliant, easy to follow and will pass FDA scrutiny, if followed.
We look forward to the opportunity of working with you!
Call us at (954) 552-0309
FDA Investigation Experience
Pharmaceutical and Medical Device Consulting
Do not be fooled by inexperienced consultants who are unfamiliar with what is legally required by the FDA or cGMPs. Using firms without former FDA consultants may only set your company up for failure and hinder your next FDA inspection.
This can occur by implementing inadequate standard operating procedures (SOPs) that are too stringent, difficult to follow, non-compliant or require more work than the regulation intended. Also, many consulting firms try to implement a “one size fits all” solution that has proven to be ineffective.
Our Services
Our former FDA Consulting Team has extensive experience. Many of us are retired FDA (30+ yrs) or have at least 10 years experience with the FDA, as well as industry expertise in the following areas:
- cGMP’s/QSIT/All Quality Systems
- FDA 483, Warning Letter & Consent Decree responses
- FDA Interactions/Meetings
- Mock FDA Audits; Due Diligence Audits; ISO 13485
- Pre-Approval Audits (PAI)/API Audits
- Laboratory Audits
- Bioresearch/Clinical CGP Audits
- Complaints/CAPA Remediation
- Sterile Processes
- Process Validations/OQ/PQDesign Control
- DEA Compliance audits/Florida State Licensing
- Tobacco Control Act (TCA)
- BIMO
- 21 CFR 211 and 820 Training Workshops
- Supplier Audits
- Labeling reviews
- Vitamin/Cosmetic audits
Locations
Offices in 5 states, but we travel the world helping our clients solve quality and compliance issues
Florida
West Virginia
Georgia
Colorado
Washington
Contact Us:
(954) 552-0309
dusty@xfdainvestigators.com
shane@xfdainvestigators.com