XFDA Investigators
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Welcome!

Welcome!Welcome!Welcome!

We are a group of former FDA Investigators and Compliance Officers working to bring effective, quality solutions to your firm

USA 1-760-580-7212

Welcome!

Welcome!Welcome!Welcome!

We are a group of former FDA Investigators and Compliance Officers working to bring effective, quality solutions to your firm

USA 1-760-580-7212

Our Mission Statement

As a pharmaceutical industry consulting company, our mission is to help your firm build effective, successful and sustainable quality systems that produce safe products for consumers!

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 many PAI/cGMP/QSIT and GCP inspections, it was counterproductive trying to inspect quality systems that were too cumbersome and  impossible to follow, due to the unnecessary and over-demanding requirements that had been proceduralized in SOPs, protocols, etc. This happens when employees and  consultants do not understand exactly what is required by FDA regulations or an inspection authority. My colleagues and I agree, this made our FDA Investigators job very tough!


What is most concerning to our Team is that we have seen firsthand how firms pay consultants millions of dollars and trust them to help implement quality systems that will pass FDA scrutiny.  Unfortunately, these same firms are receiving significant observations, warning letters (OAI) or worse from their FDA inspections.  


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 and GMP inspections; we have 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.


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!  


Contact us at USA 1-760-580-7212 or use our contact form below, or send me an email at dusty@xfdainvestigators.com

FDA Investigation Experience

Pharmaceutical and Medical Device Consulting

Pharmaceutical and Medical Device Consulting

Pharmaceutical and Medical Device Consulting

We offer 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

Pharmaceutical and Medical Device Consulting

Pharmaceutical and Medical Device Consulting

Former FDA investigators

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/BIMO/Clinical GCP Audits
  • Complaints/CAPA Remediation​
  • Sterile Processes
  • Process Validations/OQ/PQ 
  • DEA Regulation expertise for DEA regulated products/DEA State Registrations/Medical Marijuana registration 
  • Veterinary Products
  • Tobacco Control Act (TCA)
  • BIMO​
  • 21 CFR 211 and 820 Training Workshops​​
  • Supplier Audits​
  • Labeling reviews​
  • Vitamin/Cosmetic audits

Contact Us

How Can We Help You?

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XFDA Investigators

(760) 580-7212

Hours

Mon

09:00 am – 05:00 pm

Tue

09:00 am – 05:00 pm

Wed

09:00 am – 05:00 pm

Thu

09:00 am – 05:00 pm

Fri

09:00 am – 05:00 pm

Sat

Closed

Sun

Closed

 USA 1-760-580-7212 | dusty@xfdainvestigators.com | shane@xfdainvestigators.com

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