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.

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

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Martin VanTrieste
Vice President Quality; Commercial Operations

Amgen
One Amgen Center
Mail Stop: 92-2-D
Thousand Oaks, Ca  91360-1799
Direct: 805.313.1524