FDA Cites "Shadow" Heparin Manufacturing Plants in China

Some of those in favor of relaxed reimportation often argue that the drug industry is fear mongering when it points to potential safety problems with drugs or ingredients sourced from abroad. "Be afraid, be very afraid. "  Well, recent events have shown that there is reason for fear....or at least for extreme caution when ensuring the pedigree of any raw materials  sourced from abroad. 
That is the message conveyed in this recent update from Martin Van Trieste, VP at Amgen via the ISPE LinkedIn Group.  Mr. Van Trieste, who is heavily involved in the new consortium Rx-360, alerted group members of two fake heparin Chinese manufacturing plants...Rx 360 will hold a key meeting in June, and Mr. Van Trieste recently discussed its mission with Gary Ritchie in this brief video.

Here's more from the source:

Today, two Warning Letters were issued by the FDA which only highlighted the necessity for Rx-360 to be successful. From reading these FDA issued Warning Letters it appears that the FDA uncovered a “Show Factory” at Shanghai No. 1 Biochemical & Pharmaceutical Co. Ltd, and its “Shadow Factory” at Qingdao Kangyuan or Qingdao Jiulong.

The FDA Warning Letter stated: “The inspection revealed that the facility was not manufacturing, and did not appear to have ever manufactured, Heparin Sodium USP (or heparin sodium) for the U.S. market. The investigators also determined that, contrary to your firm’s claims, manufacturing of heparin sodium was conducted at facilities other than the one identified in your DMF. In addition, our review of information submitted to the Agency in your DMF 12281, as well as documents collected during FDA’s inspections of both your facility and of subcontractor Qingdao Jiulong, along with additional information, uncovered untrue statements and information submitted by your firm to the agency with respect to the actual manufacturer(s) of heparin sodium. “

The Warning Letter also stated: “The investigators also found that the manufacturers’ labels had been removed from the 5 kg bags during the repackaging operation and the bags were placed inside aluminum drums used to ship the heparin sodium to the U.S.; the bags were then sealed and identified with the Shanghai No. 1 label.”

Finally the Warning Letter stated: “Although this heparin sodium (148 lots) was shipped to the U.S., we note that no drug products made with these lots have been marketed in the U.S. at this time.”

The following are links to the referenced FDA Warning Letters:

http://www.fda.gov/foi/warning_letters/s7159c.pdf

http://www.fda.gov/foi/warning_letters/s7160c.pdf

We should all be aware of these types of events and increase our diligence when selecting and auditing suppliers.

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AMS