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; or shane@xfdainvestigators.com
