USA-based injectable drug manufacturer Hospira has disclosed in a U.S. Securities and Exchange Commission filing that the company had received a warning letter from the U.S. FDA following an inspection of the company’s manufacturing facility in Victoria, Australia.
The inspection of the Australian manufacturing facility, which took place in late February 2014, identified "significant violations" of current Good Manufacturing Practices, including Hospira not thoroughly investigating unexplained discrepancies or why a batch failed to meet specs.
The warning letter does not restrict production or shipment of Hospira's products from the Australian facility.
The warning, however, comes right as it appeared Hospira was out of the woods in terms of quality issues. In the passed two years, Hospira has received FDA warning letters in regards to two facilities in the U.S. -- Lake Forest, Illinois and Rocky Mount, North Carolina -- and two plants in India. A series of recalls involving human hair and glass particles in the fall of 2013 added to quality concerns.
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