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from by: Randi Hernandez

hospiralogoHospira announced on Oct.1, 2014 that it received a warning letter from FDA regarding its manufacturing plant in Mulgrave, Australia. In the letter, FDA reprimanded the manufacturer for not addressing “significant violations of current good manufacturing practice” the agency observed earlier in the year.

According to FDA, Hospira failed to investigate discrepancies or failures in batches of drugs, specifically, the out-of-specification (OOS) results from stability studies in multiple batches of mitoxantrone injection. FDA also noted Hospira did not take the proper action in respect to the affected batch when it was determined that oxygen in the headspace of the vials was the cause of the OOS results. FDA wrote about the oxygen, “we remained concerned that you do not know the actual levels of this impurity in distributed lots of [M]itoxantrone [I]njection.”

The letter to Hospira also cited the lack of corrective and preventive action to address visible crystal particulates in its carboplatin injection drug product. In addition, the letter said Hospira failed to create an adequate system for checking environmental conditions in aseptic processing areas.

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Chris Hebel

About the author - Chris Hebel

More than 20 years experience at early stage Biotechnology companies encompassing both product/process development work and entrepreneurial business development work. Mr. Hebel now acts as a consultant to early stage companies developing and commercializing various biotechnology products based on cutting edge technologies.

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