Hospira Warned Over Manufacturing Violations at Injectables Plant
The FDA issued a warning letter to injectables giant Hospira after an investigation of its Victoria, Australia, plant uncovered significant good manufacturing practice violations, including a failure to adequately investigate failed batches and determine levels of impurities in distributed products.
Agency officials investigated the facility between Feb. 24 and March 1. Hospira’s responses to the resulting GMP observations so far have lacked sufficient corrective actions, the FDA said in a Sept. 26 warning letter, which Hospira disclosed in an SEC filing.
For example, the letter noted, investigators found too much oxygen in vial headspaces of mitoxantrone injection. But to date, the FDA remains concerned that Hospira doesn’t know the actual levels of this impurity in distributed lots of the product, it added.
Other violations the FDA cited included: failing to provide written procedures for production and process controls and inadequate systems for monitoring environmental conditions in aseptic processing areas.
The warning letter admonishes Hospira that a failure to correct the deficiencies could lead the agency to withhold any new applications from the company or even place an import ban on the plant.
Hospira said it promised to respond fully to the violations highlighted.
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