Hospira Inc. (HSP) said it received a warning letter on April 1
from the U.S. Food and Drug Administration saying the specialty
drug maker's response to findings last year of quality issues at a
plant in Italy was lacking.
The Lake Forest, Ill., company said in a regulatory filing on
Tuesday that the FDA warning letter doesn't restrict production or
shipments from the plant in Liscate, Italy. Hospira said it is
evaluating possible corrective actions and related costs to address
issues raised in the warning letter.
Among problems with the Italian plant, the FDA said
investigators found Hospira failed to establish and follow
appropriate written procedures to prevent potential contamination
and that its quality-control systems didn't adequately ensure the
accuracy and integrity of data it generated to support product
quality.
The FDA requested Hospira to provide a plan to investigate the
extent of deficiencies in its documentation processes, a risk
assessment of the potential impact on drug quality and plans to
correct violations and prevent future ones.
The disclosure comes about a week after Hospira said it would
need regulatory approval to sell products made at one of its
locations in India, after an inspection found several potential
violations.
Problems with Hospira's manufacturing quality in recent years
have contributed to product shortages and recalls.
Write to Tess Stynes at tess.stynes@wsj.com
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