Fisher & Paykel Healthcare Receives FDA Warning Letter

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

Contact: Michael Daniell MD/CEO on +64 9 574 0161.