October 1, 2014 — In a regulatory filing, Hospira Inc. has reported receiving a warning from the FDA for “significant violations” of good manufacturing practices.
The warning was issued after inspectors documented problems at a facility in Australia during February and March 2014. The biggest problem was that Hospira took “no effective corrective action” after receiving complaints about visible crystal particles in finished vials of carboplatin, an injection drug for chemotherapy.
In May 2012, Hospira received a notification that visible particles were identified in the drug. In September 2012, a customer complaint confirmed that crystal-like particles were present in some samples of the drug. An investigation also reported fiber-like particles, but Hospira concluded that the root cause could not be determined.
It was not until December 2013 — 15 months after the investigation began — that Hospira confirmed that there were crystal particles in some products. It was not until March 2014 that Hospira issued a “Dear Healthcare Provider” letter recommending a visual inspection of the vials prior to use and a filter before administration.
The FDA is concerned that Hospira still has not fixed the problem. According to the warning:
“Despite the investigational efforts from 2012 to 2014, your firm has not implemented adequate corrective action related to the presence of crystal particles in your carboplatin injection drug. We remain concerned that crystal particles are intermittently observed in reserve samples.”
Despite these serious problems, the FDA has not ordered Hospira to stop manufacturing or exporting products into the United States. Instead, they gave Hospira 15 days to respond with specific steps they intend to take to correct the problem.
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