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Hospira Receives FDA Warning for Drug Manufacturing Violations

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The Food and Drug Administration has sent a warning letter to Hospira Inc. over “significant violations” of current good manufacturing practice (CGMP). The FDA said the company has not taken adequate steps to correct the violations, which include “visible particles” in lots of a chemotherapy drug.

In an inspection conducted from February 24 to March 1, 2014 at Hospira’s manufacturing facility in Mulgrave, Australia, FDA inspectors discovered “visible particles” in an injectable drug, The Chicago Tribune reports. The company said it is considering what corrective actions it needs to take but said it intends to respond fully to the warning letter. At this time, the FDA is not restricting the production or shipment of pharmaceutical products from the Mulgrave plant, but could do so if the violations are not corrected.

The FDA cited Hospira for failing to properly investigate batch failures and product discrepancies, and failing to fully correct various problems found at the Mulgrave plant. The company failed to set up an adequate system for monitoring aseptic processing areas, the letter says. “Your firm failed to establish written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess,” the letter states.

According to the warning letter, the issue with particles in the chemotherapy drug carboplatin dates back to 2012, but Hospira did not contact health care providers until March 2014 to recommend visual inspection of the vials and use of a filter before administration of the drug.

Hospira has 15 business days from receipt of the letter to tell the FDA the steps it has taken to correct the violations. The FDA could refuse to admit the plant’s products into the United States if the violations are not corrected. disclaimer: This article: Hospira Receives FDA Warning for Drug Manufacturing Violations was posted on Tuesday, October 7th, 2014 at 4:46 pm at and is filed under Defective Drug Lawsuits.

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