A video excerpt from The Windshire Group's webinars on demand: FDA Inspections: The Difficult, The Odd and How The Firm Resolved 12 Real-Life Scenarios. In this 58-minute webcast, Danielle DeLucy, a veteran of 200+ regulatory inspections, provides 12 real-life scenarios that occurred in FDA inspections, including; Opening Day, Documentation, Safety and Inspection team situations, etc. - Read More: https://windshire.com/shop/
The FDA Inspector Takes Issue with the Product Specification - Transcription:
Another case study for a subject matter expert, this also happened at another table while I was in the inspection room and this is a final container test was being discussed between an SME and an investigator. The FDA person actually took issue with the specification that the company had set for the product. As you all know specifications are set forth when the product is licensed, so obviously this specification was licensed by FDA, but the subject matter expert didn’t really do a very good job in keeping calm, so the conversation took a turn for the worse. And then the inspector actually refused to further discuss the issue with the assigned SME. The inspector then suggested that FDA headquarters will be called to discuss the matter. So I can tell you this was probably one of the most uncomfortable and awkward situations and really critical situations I was able to witness at a firm. The SME was quite confrontational. There were some not so nice words exchanged between the FDA investigator and the SME. She then refused to speak to him because she didn’t feel like she was getting anywhere with him and then she really wanted to take a break and said that maybe she should call her headquarters to see what she should do. So the firm, they took a break. We said, let’s get upper management involved. What we did was we gathered the drug license to show the final package specification was approved by FDA upon the original submission. We showed it to the inspector and said, you know, hey, you may not like this specification that was set forward, but your colleagues, your upper management did approve this upon drug licensing. She reluctantly accepted the file, but she didn’t stop there. She said, you know what, I’m going to discuss this matter with my headquarters after the inspection is over to see if we can really get this specification changed because I don’t agree with it from a scientific point of view and I really want to really investigate that. So this did not become a 483 citation because according to the documentation placed in front of her, we did nothing wrong. However, it goes to show you that even when you do follow the right procedure, it could arise these situations where both the SME and maybe investigator do become confrontational. It becomes very awkward and a critical situation that really needs to be solved right away so that is doesn’t get out of control and really spiral out of control for the rest of the time that they are there.