Relief Therapeutics Holding AG (RLFTF)

[C504]

Here is my take in the Lilly FDA problem. The OAI was issued last November and would have required immediate all hands on deck to fix the problem, which appears to be paperwork related. The FDA is a real stickler for proper documentation. The follow up inspection, which just happened, would have focused on the previous problem first and the entire manufacturing process including quality inspection in general. It sounds like the FDA found more errors in the paperwork that could mean the processes were either not documented properly or were not being followed properly. I didn't see where they were shutdown but they will have had to explain how they are going to fix the problem, then prove to the auditors that the process has been fixed, documented and followed. The FDA may be camped out in the facility to keep an eye on things until they are comfortable that the processes are being done correctly. This may or may not mean that Lilly has to recall all the product made since the documentation infraction happened. I used to manage clean rooms for a medical device Manufacturer and have dealt with the surprise FDA inspections. I have seen how they dig when a problem is found and they have no patience for shortcuts. You document your processes and follow them to the letter.