Finding #5: The firm lacks procedures for inventory audit trail and for tracking and reconciliation of raw materials used to manufacture the ___________. Specifically:
a. The firm does not keep records tracing the use of raw material. Raw material reconciliation cannot be conducted as discarded raw materials are not documented. During the tour to the manufacturing facility on 8/6/2018, the inspection team observed a ____L container of ____________ in the loading dock for destruction. The material could not be traced.
b. Warehouse raw material inventory list is kept in an Excel Spreadsheet that lacks history traceability. During the tour of the warehouse on 8/6/2018, Warehouse inventory cannot be located using the Excel Spreadsheet. Specifically, ________ (catalog #____ Lot #______) was present in the warehouse, however the location and inventory could not be provided.
c. The warehouse is not adequately mapped for inventory purposes with floor plans. Items stored on the floor have no assigned location. In addition, quarantine and released items on the floor are kept side-by-side without a system in place to prevent the use of quarantined material.
My comments: Wow. I gotta hand it to the FDA. They were really paying attention. Again, IMMU is lacking clarity in their procedures, or rather, a procedure altogether. This time, it’s for the tracking of raw materials, which they had issues with verifying were clean in the previous finding. You’ll want to be able to track the lots if some of them are CONTAMINATED like was found in finding #4!
a. Traceability is everything in medical devices. Gotta know where your materials came from because that pedigree (along with good testing) will ensure its safety for use in assembly of the final product. IMMU does NOT keep records tracing the use of raw materials. As late as 8/6/2018 they were unaware of this basic guideline to good manufacturing practices (GMP).
b. Warehouse inventory shouldn’t be kept via Excel spreadsheet (though it’s not uncommon for small startups to do so because they can’t afford the big supply chain management softwares and can’t afford the people to run them). The problem with Excel spreadsheets to the FDA is that there’s no traceability and tracking of changes that are made on the info in it and all it takes is one fat finger for all traceability to be lost.
c. So it seems like IMMU does quarantine stuff, which is a good thing (see my post on finding #3) if you actually label it so people know it’s OFF LIMITS. Certainly don’t keep it side-by-side with RELEASED ITEMS that are “good-to-go”. This is just…I can’t even…
Guys, at this point…I don’t know if I need to continue my review. I’m saddened and sorry that I didn’t have the chance to get to this before the 17th so I could tell you all that there’s no way in hell I’d approve a company that runs like this. At the VERY LEAST, I’d want to come back and see that they’re working on this stuff so…CRL until I do.
I remember seeing the 483 and reading some posts here that were very reassuring that management had it handled. Feeling comforted and not having that much time to pour over this, I let it be and sunk back into my comfy “IMMU has a 90% chance of approval” chair. Complacency. We must be careful, as a group, to not drink our own kool-aid and take care to exercise healthy doubt. I’ve failed you guys because had I read and started dissecting this earlier while noting the dates of inspection, I’d have sold and waited to see what happened because the future definitely became uncertain based on this 483.
For management to be “blindsided” by the CRL potentially means a few things:
1. They’ve hired a bunch of yes-men that are spineless and refuse to bring up even the most obvious of potential showstoppers.
2. They don’t really know the manufacturing game and how the details can make or break approvals.
3. Pehl’s not as involved with the day-to-day as we need him to be. Or the guy he’s delegated “walking the floor and making sure there’s nothing out there that could ruin our chances” to isn’t up to the task.
4. A lot of heads have rolled since management came in and that's why there was a hiring frenzy and those hired in that frenzy reassured Pehl and crew (incorrectly) that things were going to be fine.
The above are just some cathartic conclusions I've drawn but I think at this point, I’m pretty convinced that this will be at least a Class 2 submission based on IMMU needing reinspection (in my opinion) unless the company has worked some miracles between August and now. But that's not likely based on their performance in August. I will admit that I don’t know what a breakthrough designation will buy a company in terms of FDA leniency but I can’t imagine they’d let so many issues go un-checked (re-inspection) which would connote a class 2 submission. This is just an opinion though. Please take it with a grain of salt and whatever other spices you prefer. |
