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Impurities, particulates, and a lack of communication are among Hospira's recent violations described in a warning letter from FDA.
Hospira 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.
FDA gave the manufacturer 15 days to notify the agency that they have taken corrective action to fix the violations. FDA stated that they would withhold approval of any new applications or supplements listing Hospira as a manufacturer unless this written explanation is received, and may refuse admission of articles into the United States manufactured by the Mulgrave location.
Hospira acknowledged the violations in an 8-K filing, and said that even though there is no assurance FDA will be satisfied with its response, the company intends to respond to the agency’s concerns. Hospira also stated that any further action by FDA could significantly affect its business operations.