K.C. Pharmaceuticals just recalled 3.1 million bottles of eye drops. The reason: they couldn't prove the products were sterile.
Not that the products were contaminated. They couldn't prove they weren't.
Here's the part that should bother every quality manager reading this. The FDA inspected this same facility in 2023. Found the same type of issue. Inadequate procedures for preventing microbiological contamination. They issued a warning letter. Told K.C. to fix their protocols and bring in outside experts.
Three years later, 3.1 million bottles. Eight product lines. Sold at Walgreens, CVS, Kroger, Rite Aid, Publix, Dollar General. Class II recall.
The corrective action didn't work.
I think about this pattern constantly because I see a version of it in almost every shop I visit. The audit finding gets documented. The CAPA gets written. Someone updates a procedure. The file gets closed. And nothing actually changes on the floor.
The procedure says one thing. The operators do something slightly different. Maybe the new procedure was never trained. Maybe it was trained once and forgotten. Maybe the person who wrote the CAPA left the company six months later and nobody remembered why the procedure changed in the first place.
A closed CAPA is not a fixed problem. It's a piece of paper that says you tried.
The difference between a CAPA that works and one that just closes a file usually comes down to one question that nobody asks: did the behavior actually change? Not did the document get updated. Not did the training record get signed. Did the person on the floor do something differently today than they did before?
Most shops can't answer that question because they have no way to verify it. They verify the paperwork. They don't verify the outcome.
K.C. Pharmaceuticals had a warning letter. They had regulatory pressure. They had specific instructions from the FDA about what to fix. And they still ended up recalling 3.1 million units of product three years later for the same category of failure.
If a manufacturer with FDA oversight and documented regulatory pressure couldn't close the loop on a corrective action, think about what's happening in your shop where the only pressure is the next audit.
Your open CAPAs right now. The ones you closed last year. How many of them actually changed what happens on the floor?
One Thing to Try This Week
Pick three CAPAs you closed in the last 12 months. Go to the floor and check whether the corrective action is still being followed. Not the paperwork. The actual practice. Talk to the operator. Watch the process. If even one of the three has drifted back to the old way, you know your verification step needs work.
What I'm Reading
Generac recalled 149,400 portable generators last week after receiving 114 reports of carburetor fuel leaks during initial fueling. No injuries. They caught the pattern in the complaint data and acted before anyone got hurt. That's 114 reports across nearly 150,000 units. Less than a tenth of a percent. Most shops would look at that failure rate and call it noise. Generac looked at it and called it a recall. The difference is whether your quality system treats complaints as data or as individual annoyances to close out.
How many of your closed CAPAs would survive a floor check today?