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