Warning letter to Chinese plant: Manufacture of Heparin was dangerously unacceptable, says FDA
In a warning letter to Heparin palnt Changzhou SPL Company in China, the Food and Drug Administration enumerated the ways in which the drugmaker used faulty materials and was lax in its safety procedures.
"Your system for evaluating suppliers of crude Heparin material is
ineffective to ensure that materials are acceptable for use," the FDA said.
The Agency went on to point out to the Chinese firm that it accepted and
used Heparin crude material from a supplier that it had preliminarily determined
was unacceptable.
"Your system failed to verify that the supplier was
acceptable prior to the use of the crude material," the FDA charged.
The
FDA also pointed out that after Changzhou SPL determined that the supplier in
question was not acceptable, it failed to take any corrective action with
respect to the processed raw material.
The (FDA) said that as many as 81 deaths and hundreds of
injuries among patients taking the blood thinner heparin have been traced to a man-made contaminant from China.
If you were harmed after being
administered heparin, please complete the
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soon as possible.
see also:
Heparin Packaging
American Health Packaging Recalls Heparin Products--Free Lawsuit InfoFDA announces additional Heparin recall from American Health Packaging
Heparin Deaths
More Deaths Linked to Heparin--Get Free Legal Info if You Were HarmedCause still unknown but more deaths linked to Heparin--lawsuit info
FDA Health Advisory
FDA Issues Advisory on Heparin Due to Health Risks--Free Lawsuit InfoDid You Suffer Adverse Reaction After Heparin Injection? Lawsuit info
