See: “Clenbuterol (4-amino-(t-butylamino)methyl)-3,5-dichloro benzylalcohol hydrochloride), belonging to the family of β–agonists, is currently used as bronchodilators for the treatment of asthma in humans, as well as tocolytic agents in veterinary medicine. However, clenbuterol has been used illegally at higher dosages (ten to hundred times the clinically active dose) to promote animal growth in muscular mass, and at the same time decreasing fat accumulation. Although these properties were known in 1984, the use of clenbuterol did not become widespread until 1988 in response to the European directive forbidding the use of hormones in animal production. Even so, no standard was established for clenbuterol, or other β-adrenergic agonists, for such purposes. On the contrary, clenbuterol and similar products were included in the list of substances formally banned for zootechnical use.”

“Outbreak of illness concerning clenbuterol was reported at Hong Kong in 1997. Limits to the tissue content of clenbuterol residue in meat products have been established by law in China. However, it is difficult for Chinese government to control the illegal use of clenbuterol in swine production because there are too many individual farmers and small farmers are breeding swine in China. “

From: http://www.healthyeatingclub.com/APJCN/Volume16/vol16suppl.1/WeihuaLai(106-110).pdf

While the snafu withthe inspection IS a big deal, I am unaware of any concrete evidence to indicate the problem stems directly from the API. There are plenty of other potential causes for this sort of thing. Baxter, of course, bears the responsibility for the problem whatever it is. It is very easy in the current climate to shout about lousy manufacturing practices in China and I think Baxter is perfectly happy to blame “a supplier to a supplier.” The problem is that Baxter is responsible for the product that goes out the door and ultimately into the consumer. It’s important not to conflate the issues of FDA inspection and oversight, Chinese cGMP, and Baxter’s faulty product.

Is there not something troubling about that statement… If it were YOUR product, wouldn’t you want to know that the facilities where your product and its intermediates will be produced, passed inspection? Wouldn’t your quality assurance staff be all over your contractors and suppliers, ensuring proper regulatory control/manufacturing operations???

And having said that… do we even know the root cause of the illnesses and deaths…? Inspection doesn’t guarantee a safe product. Done properly, it can provide assurance that manufacturing systems systematically controlled… but it doesn’t confer patient safety.

What we see here is that Baxter is clueless. They don’t know their contractors, they have offered little insight into what went wrong (if anything), and they have taken little responsibility for the affected patients, beyond a delinquent product recall.