FDAnews
www.fdanews.com/articles/90411-company-warned-for-inadequate-complaint-handling-system

COMPANY WARNED FOR INADEQUATE COMPLAINT HANDLING SYSTEM

January 24, 2007

After the FDA warned Tiara Medical Systems for several current good manufacturing practice violations regarding its complaint handling system, the company successfully responded to all charges, the agency said.

Tiara is the specification developer and complaint-handling unit for continuous, positive air pressure devices for Viasys Healthcare, according to the warning letter. During inspections, the FDA found that some of the firm's devices were adulterated.

The company's vice president for quality assurance replied to the agency's Form 483 after the inspection, and all of his responses were adequate, said the agency. However, the agency said it would need to conduct another inspection to make sure the corrections had fixed the cited problems.

The FDA investigator reviewed 77 complaints, nine of which lacked any complaint investigation, the letter said.

(http://www.fdanews.com/ddl/34_4/)