FDA Cites Two Local Biomedical Firms for Unapproved Activities

A federal agency disclosed Tuesday that it has cited two Orange County biomedical companies for unapproved activities--Gish Biomedical Inc. in Irvine and Imagyn Medical Technologies Inc. in Newport Beach.

The U.S. Food and Drug Administration issued a warning letter to Gish for allegedly making changes to infusion pumps it sells without clearing the alterations first with the agency.

“Major modifications or changes in design were made that could significantly affect the safety and effectiveness of the devices,” the FDA said in a warning letter.

In a separate letter, the agency cited Imagyn for statements made on its Internet Web site that promoted the company’s diagnostic system for unapproved uses. The agency said the statements suggested the system can be used both to view an entire Fallopian tube and to help unblock the tubes. Regulators said the device is approved only for viewing a portion of a tube and for more limited use in procedures.

Gish and Imagyn officials said they are taking steps to meet the agency’s concerns.

Jeanne Miller, Gish’s vice president and chief financial officer, said its infusion pumps, used by patients at home, had been acquired when Gish bought Creative Medical Development Inc. in 1996 and that Gish has stopped selling them because of the FDA’s concerns.

“The problems with the product were inherited,” Miller said. “We have been in the process of doing a complete redesign.”

Imagyn spokesman David Pyrce said the company has fixed its Web site. The Internet site belonged to Imagyn Medical Inc., which became part of the company in September, he said.