I recently asked Celltex if they had definitely convinced the FDA their product was not a drug (i.e. the FDA confirmed their product was not a drug) or rather they had tried and hoped they had. It appears the latter is correct from the Celltex response below:
Dear Dr. Knoepfler,
Thank you for your interest in Celltex. In your latest inquiry, you sent two interrelated questions, both asking for FDA’s thinking. We cannot speak on behalf of the FDA. We maintain an open, positive dialog with FDA. FDA’s oversight of our operations will continue as we are providing HCT/P services. For example, we anticipate, and welcome, a return visit from the FDA before the end of this year, consistent with the agency’s typical practice for following up on a 483. We are operating as an HCT/P facility and FDA is fully aware of that fact. Sincerely,
The Celltex Team
Based on talking to many experts in the field, I disagree with Celltex. In my opinion the FDA will remain steadfast that Celltex is in fact operating a drug manufacturing facility (as was how the FDA described Celltex on the 483 report), not an HCT/P facility. I could be wrong of course.
Interestingly, the answer above also reveals that Celltex is expecting a 2nd visit from the FDA relatively soon.
Kudos again to Celltex for engaging in this dialogue with me.