The CEO of Baxter Healthcare said that the company doesn’t know enough about its Chinese supply chain that made the active ingredient for heparin. Heparin has been recalled nationwide because of deaths and serious adverse reactions.

Baxter CEO also claims to know that the prime ingredient was never inspected by the U.S. FDA before it was shipped to the Scientific Protein Laboratories, a U.S. supplier with manufacturing in China.

Scientific Protein Laboratories produces the active ingredient for heparin at a plant in Changzhou, China. The plant is co-owned by Scientific and a Chinese joint venture partner. The FDA said this heparin ingredient producing plant was never inspected because its name was confused in registration materials with a different company that had been inspected.

Heparin is used in surgery, dialysis, and for the bedridden. While other drugs thin blood, they are deemed to be not as effective. Heparin has been manufactured since 1930 and is administered to millions yearly. Baxter manufactures about half of all multiple-dose heparin vials sold in the United States.

Since late 2007, the FDA said it received reports of four deaths and about 350 other health problems associated with Baxter’s heparin about 40 percent are considered serious.

Baxter stopped manufacturing heparin last week. The FDA began reviewing the plant in China on Wednesday. The FDA said Chinese regulators do not inspect plants that produce strictly for export.

The best way to ensure the highest quality of raw material is to have American-trained inspectors in China who understand a high level of good FDA manufacturing guidelines.

Meanwhile, the Democrats Blame FDA for Failing to Inspect Heparin Making Plant in China according to reports published in the Chicago tribune. Two members of Congress are posing the query as to whether laws are needed to ensure that the FDA follows its own inspection guidelines. The FDA failed to inspect a Chinese facility that supplied the main active ingredient for Baxter Heparin. Production was stopped in February 2008 after heparin was linked to four deaths and hundreds of allergic reactions. The FDA said the Chinese plant was not inspected because of confusion stemming from its name.

But according to the FDA's own guidelines, agency officials should have inspected the plant before any shipments entered the United State. The regulation has been in place more than 20 years, though neither companies nor FDA are required by law to conduct pre-shipment inspections.

Lawmakers sent a separate letter to Baxter questioning whether the company knew the FDA hadn't inspected the source of its drug's ingredient and to hand over all correspondence with the FDA regarding the Chinese plant.

But the FDA Claims Missed Heparin Plant Inspection an Isolated Incident. This is almost laughable if four people didn’t already die as well as over 300 serious adverse reactions to heparin injection.

Now the FDA is claiming that FDA mistakes happen rarely. How many FDA inspectors are available to inspect all the toys that have been poisoning your children? The FDA will be going to China to inspect the Chinese plant that makes the prime active ingredient for Heparin this week as well as the Wisconsin supplier Scientific Protein Laboratories and then to Cherry Hill, New Jersey to inspect the final Heparin multi-dose vials.

Heparin is used before kidney dialysis and heart surgeries as a blood thinner to prevent blood clots.

The cause of the heparin adverse effects is unknown. Hopefully a full on inspection will remediate the cause.