A simmering dispute between a Utah injection molder of medical devices and the Food and Drug Administration boiled over Feb. 11, when the company publicly accused the agency of unfairly blocking its exports.
Injection molder Utah Medical Products Inc. took the unusual step of issuing a statement saying that FDA was subjecting it to ``wasteful'' and intrusive inspections, and it urged Congress to investigate.
At issue is an FDA decision in April to deny UM export certificates for South Korea and Ecuador, after agency inspectors decided that the Midvale, Utah-based company was not following good manufacturing practices, including poor record keeping and inadequate quality control.
FDA inspectors told the company that it had not corrected problems first found in a 1995 inspection. UM, which makes products for women giving birth and for babies, sued FDA in June to force it to grant the export licenses.
UM Chief Executive Officer Kevin Cornwell said there have not been any problems or recalls of UM products, and that FDA continues to allow the products to be sold in the United States.
FDA officials could not be reached for comment.
FDA has inspected UM's quality systems four times in the last three years, according to UM, and three inspectors have been examining its Midvale plant since Feb. 2.
``We invite our congressional representatives who have a keen interest in the public welfare to use our experience in a formal investigation of FDA practices,'' Cornwell said in a statement.
A spokesman for Utah Sen. Orrin Hatch said his office had been contacted by UM but was still examining the situation.
The firm does not legally need FDA approval to export its products, but some countries require FDA certification that the firm complies with U.S. laws as an additional comfort factor, Cornwell said.
The loss of the export certificates reduced the company's international sales by 6 percent in the second half of 2003, after they rose 12 percent in the first half of the year, UM said.
UM said its manufacturing processes have met ISO 9001 and EN 460001 standards since 1994, and now meet the more stringent ISO 13485 standard for medical devices.
The company makes proprietary medical devices using a variety of processes. The firm had net sales of $27.1 million in 2003.