FDA Warns Hospira over Manufacturing Violations

The U.S. Food and Drug Administration (FDA) issued a warning letter to Hospira over manufacturing violations at an injectables plant in Australia. According to Wednesday securities filing, inspections in late February and early March revealed “significant violations” of drug manufactured protocols.

According to FiercaPharma, the agency found crystal particles in carboplatin injects. The FDA says Hospira failed to remedy the problem, and only warned doctors to inspect the chemotherapy drug months after the problem was noted. According to the FDA, Hospira has still not corrected this issue because the particles still appear in reserve samples. The letter says that the company failed to properly investigate failed batches and discrepancies between products.

This is not the first time the FDA has cited Hospira for safety issues. The company has had several recalls and warning letters. In several cases, the issue was because of drug vials contaminated with particulates. One lot of heparin injection was recalled last month after a customer reported finding a human hair in a vial. Stainless steel particles in a vial prompted a recall of labetalol hydrochloride in May. Additionally, the FDA has focused in on some problems at a Hospira plant being built in Vizag, India.

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