* FDA sends CSL unit letter following inspection
* Agency faults CSL over manufacturing practices
* FDA requests meeting with CSL senior management
WASHINGTON, June 28 U.S. health regulators have
cautioned Australia's CSL Ltd (CSL.AX) after uncovering
problems at its influenza vaccine manufacturing plant and want
to meet with company officials, according to a letter released
The U.S. Food and Drug Administration inspected the
company's CSL Biotherapies unit, that makes Afluria and H1N1
monovalent vaccines, and found it was not following some of the
agency's good manufacturing guidelines.
The agency also called on senior CSL managers to meet with
FDA officials, something the agency does not often ask for in
While a setback for CSL, the findings are unlikely to
severely affect the U.S. flu vaccine supply. The FDA did not
ask the company to halt production at the Australia-based
manufacturing plant, and four other drugmakers are approved to
sell such products in the United States.
Merck & Co Inc (MRK.N) has exclusive rights to sell and
distribute Afluria seasonal flu vaccine in the United States
starting with the 2010-2011 flu season under a 6-year deal.
Other major influenza vaccine makers that supply the United
States are Sanofi Aventis SA (SASY.PA), Novartis AG NOVN.VX,
AstraZeneca (AZN.L) and GlaxoSmithKline (GSK.L) (GSK.N).
According to the letter, CSL's unit "failed to thoroughly
investigate any unexplained discrepancy" or batch failures. It
also failed to establish testing procedures designed to assure
components conform to "appropriate standards of identity
strength, quality, and purity," the letter said.
The letter, posted to the FDA's website at
link.reuters.com/wub64m , follows an April 2010
inspection of the company's Melbourne, Victoria facility, but
it was unclear when the agency sent the letter to CSL.
A CSL Biotherapies spokeswoman could not immediately be
reached for a comment.
(Reporting by Susan Heavey; Editing by Tim Dobbyn)