FDA SAYS CURRENT INSPECTION PROCESS FINE AS IS

The FDA has not changed its inspection policies in the device program area, despite a court ruling last year that favored devicemaker Utah Medical in its challenge of those policies, agency spokeswoman Heidi Valetkevitch said.

After winning its case against the agency, Utah Medical asked HHS to review the firm's allegations that FDA inspectors and staff were overly aggressive -- even "abusive" -- in enforcing the agency's quality system regulation.

The FDA considers Utah Medical's allegations and complaints to be unsubstantiated, Valetkevitch said. "The agency does review and revise its inspection policies as necessary," she added.

The FDA has "not received credible feedback from customers" that inspectors are in effect making policy through the inspection process, Valetkevitch said. "In the event the agency receives feedback from industry, it evaluates and assesses the feedback and determines appropriate action as necessary." (http://www.fdanews.com/ddl/33_42/)