Drug and medical device maker Hospira said that it received a warning letter from the Food and Drug Administration following an inspection at a company factory in Italy. The agency said it found problems with procedures that are supposed to prevent sterile products from being contaminated, and found fault with Hospira’s inspections procedures.
It also said the company should have better security protecting data generated during its manufacturing process. The FDA said analysts could have deleted or altered raw files produced by some machines and that the company couldn’t verify when some files were changed or deleted or who did it. The Lake Forest, Illinois-based company said the warning letter does not prevent it from making or shipping any products at the facility and said it is evaluating the changes the FDA wants it to make. The company said it will make a timely response.
Hospira Inc.’s products include injectable drugs and infusion devices. It is trying to get FDA approval for Retacrit, a less-expensive version of a biotech anemia drug. Pfizer Inc. agreed to buy the company in February for $15.23 billion, and the companies expect to complete the deal in the second half of 2015