Wednesday, November 4, 2015

Warning Letter of the Week: Doesn't everyone have two sets of batch records for the same process?

Someone at Bloomberg has gotten their hands on some pretty interesting FDA 483s: (emphasis mine)
A Pfizer Inc. plant in China that was being inspected by Food and Drug Administration regulators in order to ship drugs to the U.S. kept a second set of quality and manufacturing records that didn’t match official ones, according to an FDA review of the facility. 
During an April inspection of Pfizer’s plant in the northern Chinese city of Dalian, FDA inspectors said in their report that employees hid quality failures, used expired manufacturing materials or ones that hadn’t been recently checked, and retested failing products until they passed. 
Details of the inspection were described in an FDA report called a Form 483 that was obtained by Bloomberg News. Mackay Jimeson, a Pfizer spokesman, confirmed Pfizer’s ownership of the plant.... 
...At Pfizer’s Dalian plant, the agency observed that when tests of drug products failed to meet standards, the same products were re-tested until passing results were achieved, and that the original failures were never reported or investigated. 
The FDA inspectors also noticed that one manufacturing unit had only one stand-alone toilet in significant disrepair 50 yards from the aseptic manufacturing unit. Inside the facility inspectors saw no hand washing station and an open pit appeared to be used as a urinal.
The open pit is a nice touch; I'd like to see the change control for the installation of that.  

11 comments:

  1. Note to self: stay very healthy.

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  2. Reporting only the good is no surprise. The yield of every organic chemistry reaction ever reported is only the one that was deemed "good enough" after repeating that reaction at least half a dozen times with poorer yields that will never see the light of day. That's how science is supposed to look!

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  3. So much for the wonders of outsourcing. Anyone who has lived and worked in mainland China could have predicted this debacle.

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  4. Anonymous, that's how academic chemistry works. You can't retest a failing lot of drug product without a good reason if you are going to comply with the FDA's guidelines for drug manufacture. And regardless, you must report the first failure.

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  5. Anyone who works in Pharma and is shocked by this hasnt been paying attention for the last 10 years or so.....

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  6. and yes we said this would happen but no one was listening

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  7. I suggest the Dalian plant hire Edward Haskell* Consulting and learn how to cover up better.

    * https://en.m.wikipedia.org/wiki/Eddie_Haskell

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  8. The change control log for the open pit would probably show the addition of a shovel-full of lime every other week.

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  9. Dishonesty and deceptions always win in China!

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  10. And here I thought that if I ever got some new drug still on patent that would be a virtual guarantee that the drug that was 100% active as intended....

    And we (the US taxpayer) subsidize this industry? If Medicare is going to pay list price for drugs maybe the US should demand that the drugs are made in the USA. But I guess that would make the determined drug companies raise their prices even more....

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  11. I like Pfizer's comments; "Well, we didn't kill anyone, so you don't need to worry about this." I can almost hear the subconscious whisperings of management: "Please, (deity), don't let anything happen until my bonus check clears."

    When you send your manufacturing off to Cheapsville, don't look at it too closely (other than the bottom line), and know that no one else is going to have time to look closely and regularly, well, this is going to happen. That not outsourcing your core business thing seems like a quaint memory.

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