FDA Cites Pfizer Over Contaminated Vials at Hospira Facility in Kansas

Pfizer’s Hospira is drawing scrutiny from the FDA in a warning letter for failing to fully investigate quality defects, such as the presence of cardboard, in batches of injections and neglecting to take corrective measures.

FDA investigators inspected Hospira’s Kansas facility and found the firm received several complaints about particulate matter in a number of vials of injections — including containers of vancomycin hydrochloride and ketorolac tromethamine — but closed investigations into the complaints before determining the extent of the contamination and resolving the problem.

Hospira looked into the contaminations by identifying sources and the contaminants, but the firm acted slowly to correct the discrepancies, waiting more than four months to recall one lot of vials after receiving complaints and finding that the products contained cardboard, the FDA said.