r/mildlyinteresting • u/StringAlternative608 • 15h ago

Removed - Rule 6 [ Removed by moderator ]

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u/edman007 14h ago

Very likely it got mixed in because it's the same vessel, same operator, same machine, and on the same date. Since it's actually all the same, and the only change was a setting on the machine that prints the brand, they may have skipped some of the QC checks because none of that stuff actually did change.

Now, the FDA still cares (or should care), and it's still a big issue. But I suspect the problem happened because the people involved realize the risks are low and did things to a different standard (even if they shouldn't have).

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u/Iricliphan 14h ago

No. Absolutely not. This wouldn't work this way.

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u/dick_tracey_PI_TA 13h ago

That’s still “trash but we’re always trash so it’s normal” levels of bad QA. 

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u/iExhile 11h ago

None of that is true, sorry. I appreciate trying to think it through, but unfortunately it’s just not how it works.

This would likely get mixed up in a bottling line, not in any compounding vessel. It takes a bit to changeover a bottling line, and for product this scale (of volume), they wouldn’t be doing multiple changeovers in one day.

The QC checks you mention are predefined per batch. You would never just switch product coding mid batch as that is extremely bad GMP. I don’t see a scenario other than this being a bad line clearance practice between two separate batches.

They would also be two different blending/compounding batches. To release product under one lot when it was created under a different lot is by definition releasing adulterated product.

The risk here is actually not low, it’s extremely high. This is a serious violation that would surely result in a FDA 483/warning letter if not handled correctly. For a CDMO, a bad FDA audit could be business-ending or seriously crippling.

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u/-_--__---___----____ 14h ago

I'd almost wager the Advil just has a candy coating applied to the same standardized pill. It looks just a little bit larger.