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Fisher & Paykel Healthcare, New Zealand's largest medical equipment maker, said its US arm received a warning letter from the Food and Drug Administration about how it dealt with complaints.
The FDA found faults during an inspection late last year of Fisher & Paykel Healthcare's Orange County, California, sales and distribution facility, the company said.
"It was to do with procedures in relation to complaint handling and training," chief executive officer Michael Daniell said. Fisher & Paykel gets about 47 per cent of its sales in North America.
- BLOOMBERG