Rosalind
Deeply Rooted
This is incorrect, sorry--their problem was with medicines manufactured in Ft Washington, Pennsylvania (just outside Philly) at their McNeil facility. From what the FDA citation says, they were hiring unskilled labor untrained in the relevant regulations (21CFR) and giving them no particular instructions, buying any white powder labeled with the chemical name whether it was that chemical or not, not running their equipment correctly, they were previously cited and knew that they had issues but sat around on their thumbs and did nothing, they had complaints from consumers and STILL sat around doing nothing, the QC lab fudged its numbers even though they knew that some batches had almost no drug in it and other batches had a lot more drug in it (due to unskilled labor not running the mixers properly), access to labels was not controlled (any fool could label anything "Children's Tylenol" whether it was that or not), their QC sampling technique was poor, many of the raw materials had bacteria and mold growing in them, equipment was uncalibrated, equipment was filthy and covered in dust and crud & held together by duct tape, there was junk lying all over the place, water from the plumbing was filthy and undrinkable and was being used to make product.seedcorn said:
And yes, this was in the US, in a Philly suburb. I happen to know of a vaccines plant in that area, different big pharma but same region--had some colleagues who worked there. They reported similar issues, although not nearly that bad, and the place was eventually shut down. Apparently if you are looking to hire scientific & pharma management in the Philly/south central PA area, you'll get a lot of scumbags; there's a lot of people whose qualifications look great on paper but in real life are pretty awful. From their perspective, I'm one of those Massachusetts techie snobs who gits up on her hind legs and tells the menfolks what to do.
But now you see why I don't trust anything, even that which is made in the US. They were making children's medicine with random crud they bought from some shady character out of East Armpit, Nowhere, mixing it up with water straight out of the Delaware river, stirring a 2000 gallon vat with a teaspoon and calling it good. That's a lot of screwing up by a lot of people, not a few bad actors! That sort of thing doesn't happen without a lot of deliberate foolishness and sociopathy, you've got to have a lot of hate to feel OK about selling this to children. And I don't mean the little brat down the block who eggs your house and pesters your dog, I mean random children, some of whom are probably even good kids. Lots of people in the company had to know about this and think it was peachy-keen. I keep harping on that, but this is not something that can be explained away by a lame HR screening procedure that lets a few bad apples through--this is humanity being basically evil.
