Fisher & Paykel Healthcare Receives FDA Warning
Fisher & Paykel Healthcare Receives FDA Warning
Auckland, New Zealand, 9 February 2007 -
Fisher & Paykel Healthcare
Corporation Limited (NZSX:FPH,
ASX:FPH) advises that its US operating
company, Fisher &
Paykel Healthcare Inc., has received a warning letter
from
the United States Food and Drug Administration
(FDA).
The FDA's warning letter relates to deviations
from the US Quality System
regulation observed during an
inspection of the company's California sales
and
distribution facility in late 2006.
Since the FDA
inspection, Fisher & Paykel Healthcare has implemented
a
number of immediate corrective actions and has been in
close communication
with the FDA to address the
inspectional observations. The company
continues to work
collaboratively with the FDA to ensure that any
remaining
issues are promptly resolved to the FDA's
satisfaction.
The company believes it will fully satisfy
the FDA's requirements and that
there will be no material
affect on its business.
About Fisher & Paykel
Healthcare
Fisher & Paykel Healthcare is a leading
designer, manufacturer and marketer
of heated
humidification products and systems for use in respiratory
care
and the treatment of obstructive sleep apnea. It
also offers an innovative
range of neonatal care
products. The company's products are sold in over
110
countries worldwide. For more information about the company
visit
www.fphcare.com
Ends