(Adds Momenta disclosure background, Pfizer share price)
Feb 28 The U.S. Food and Drug Administration
said Pfizer Inc's process for manufacturing sterile
injectable drugs at a plant in McPherson, Kansas, was "out of
control" and put patients at risk, according to a warning letter
made public on Tuesday.
In the Feb. 14 letter, the FDA said several products were
contaminated with multiple foreign particulates and that the
injectable antibiotic vancomycin had been compromised by
cardboard pieces. The FDA warned the company it had failed to
take corrective action.
Pfizer shares were off 0.8 percent at $34 in afternoon
The presence of the foreign matter is "unacceptable" and
suggests "a significant loss of control in your manufacturing
process" that represents a "severe risk of harm to patients,"
the FDA said in the letter.
Pfizer has been "diligently implementing commitments made to
the FDA" to ensure the agency’s concerns are addressed, it said
in a statement.
Pfizer also produces treatments for other companies at the
plant. On Feb. 17, Momenta Pharmaceuticals Inc
disclosed that regulatory approval of Glatopa to treat multiple
sclerosis, its generic competitor to Teva Pharmaceuticals'
Copaxone, was on hold because of the warning letter at the
Momenta said glatopa approval was contingent on Pfizer
satisfying the FDA on compliance. The Pfizer letter does not
The warning letter followed a FDA investigation between May
16 and June 8, 2016 at the central Kansas facility that Pfizer
acquired with its $17 billion deal for Hospira in 2015.
Pfizer said the problems "do not have any impact on products
that are currently on the market that were manufactured at the
The FDA said the company's investigation was "inadequate,"
adding that similar manufacturing violations had been found at
other facilities in the Hospira network going back several
"These repeated failures at multiple sites demonstrate that
your company's oversight and control over the manufacturer of
drugs is inadequate," the FDA said.
(Reporting by Toni Clarke in Washington and Caroline Humer in
New York; Editing by Bill Rigby and Jeffrey Benkoe)