The US Food and Drug Administration (FDA) criticised the US company Tyco Healthcare yesterday over its failure to set up proper testing procedures at one of its Irish manufacturing plants.

It also threatened to detain devices manufactured at the plant upon entry to the US unless Tyco Healthcare took prompt action to correct the problem.

The warning issued by the FDA followed an inspection this year at Tyco Healthcare's plant, which manufactures ventilators, oxygen therapy products and a range of other medical devices.

A letter published by the US regulator yesterday said Tyco Healthcare had failed to set up proper procedures to verify its products at its Galway plant. The FDA also highlighted a lack of procedures to handle complaints in a timely fashion and to take corrective action, in a letter to Tyco Healthcare's chief executive and president, Richard J Meelia.

The letter notes that complaints associated with Tyco Healthcare's Galway operation, called Nellcor Ireland, had been open since 2004 and not been closed by the time of the March 2005 FDA investigation.

"The specific violations noted in this letter . . . may be symptomatic of serious underlying problems in your firm's manufacturing and quality assurance schemes," it says. "You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance."

The letter notes that Tyco International's vice-president of regulatory affairs, David Olsen, responded to the FDA's findings in March 2005, May 2005 and June 2005. It deemed these responses to be inadequate.

"Failure to promptly correct these deviations may result in regulatory action, which may include detaining your devices without physical examination upon entry into the US," it says.

Healthcare firms with significant operations in the Republic have fallen foul of US regulators in the past. In 1999 the FDA found "systematic problems" with the way that an Abbot plant in Chicago designed and manufactured its diagnostic medical tests.

Abbot was fined $100 million and the firm was precluded from selling some of its diagnostic medical tests within the US.

Abbott's European diagnostics manufacturing plants in the Republic, Britain and Germany were largely unaffected by the US problems; however, they were not allowed to manufacture certain diagnostic tests that had been imported from the US.

Responding to the FDA warning, Sharon Higgins, director of the Irish Medical Device Association, said the Irish industry had a very good reputation.

"Companies in the Republic operate under the very highest rigour of the law in a range of countries," she said. "The industry generates €6 billion in exports, employs 22,000 people and includes 13 of the top 20 global medical device firms."

Tyco Healthcare did not comment yesterday.