Shanghai Pharmaceutical - Top 12 GMP Violations

Shanghai shell game

An early August 2008 FDA inspection of a Shanghai No. 1 Biochemical & Pharmaceutical facility in Shanghai yielded CGMP violations and "untrue statements" regarding the manufacture of Heparin Sodium USP.

The inspection revealed that the facility appeared never to have made Heparin Sodium for the U.S. market. Manufacturing had taken place at facilities other than those listed in the drug master file.

"We found that heparin sodium was received at your facility packaged in 5-kg bags inside fiber drums, labeled with the names of manufacturers Qingdao Kangyuan or Qingdao Jiulong," according to warning letter WL 320-09-01. Inspectors also found that the manufacturers' labels had been removed from the bags during the repackaging operation and replaced with the Shanghai No. 1 label prior to shipping to the U.S.

Qingdao Jiulong had been referenced in a letter to the FDA as an alternate manufacturing site of heparin sodium. When the agency inspected that facility, investigators learned that the drug had also been produced at a Qingdao Kangyuan site. "This manufacturer of heparin sodium had never been inspected by the FDA, and had not been mentioned in correspondence to FDA dating back to 2001."

To make matters worse, the Qingdao Jiulong inspection had also revealed heparin lots contaminated with Over-Sulfated Chondroitin Sulfate . Some of the material had been quarantined, but "at least 19 lots were shipped to the U.S.," the letter said.

The FDA says that Shanghai No. 1 then failed to investigate the cause of "this repeated, unacceptable contamination. Instead, you requested that Qingdao Jiulong investigate the contamination, although the product was repackaged and relabeled at your facility."

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Shanghai Pharmaceutical - Top 12 GMP Violations