Hospira warned by FDA over Australian manufacturing facility

USA-based injectable generic drugs specialist Hospira (NYSE: HSP) revealed in a filing with the US Securities and Exchange Commission that it has received a warning letter from the US Food and Drug Administration related to an inspection of the company’s pharmaceutical manufacturing facility in Mulgrave, Victoria, Australia.

The inspection occurred from February 24 to March 1, 2014. The Mulgrave, Victoria site manufactures a portion of the company’s specialty injectable pharmaceutical products. Reference is made to the FDA’s warning letter, which is filed as Exhibit 99.1 to this Form 8-K, for further information.

According to the FDA letter, the site inspection revealed "significant violations" of current Good Manufacturing Practice (cGMP) rules, including not thoroughly investigating unexplained discrepancies or why a batch failed to meet specifications. The FDA also cited the lack of corrective or preventive measures implemented following repeated findings of crystal particles in its carboplatin injection drug product.