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Biotech / Medical : Immunomedics (IMMU) - moderated -- Ignore unavailable to you. Want to Upgrade?

To: Planeteer who wrote (48020)	12/10/2018 5:16:28 PM
From: erickerickson	4 Recommendations Recommended By drtom1234 erippetoe idahoranch1 Smoke Reader Read Replies (3) \| Respond to of 63277

Interestingly, this is dated 14-Aug so any reply should have been given to the FDA by early September. What I'm not clear on is when this filing was publicly available. The link is dated 7-Dec, but I have no clue whether there's a delay between the filing being available and it being published in fdanews.... On a relatively quick scan, much of this is procedural, 5b for instance: "Warehouse raw material inventory list is kept in an Excel Spreadsheet that lacks history traceability." OK, let's turn tracking on in one of the many CMS systems out there. Some of it is construction: "The design of the facility is inadequate in that no drains are present in the [redacted] rooms". Put on your hard hats, or move to a different room if you have one that conforms. And for this one, somebody's head should have rolled (emphasis mine): 1. The investigation revealed that the firm's quality control unit didn--t have the authority to investigate critical deviations that occurred at the facility -- namely a February 2018 data integrity breach, which didn--t trigger a deviation. This breach included manipulated bioburden samples, misrepresentation of an integrity test procedure in the batch record, and backdating of batch records, such as dates of analytical results. Although the actual remedy seems to be to give the QA unit more teeth. The breach, however, seems like something that is not acceptable. I also guess that the outsourced facilities already have this kind of thing in hand. AH trading is pretty quite, not sure anybody cares....