FDA Warns Thoratec Corporation on Late Filings
Published: Jan 19, 2012
Thoratec Corp. said Thursday it received a warning letter from U.S. drug regulators for filing two reports late. The maker of heart-treatment devices said the U.S. Food and Drug Administration wrote to warn it about its late filing of two medical-device reports, according to a filing to the Securities and Exchange Commission. The company said the late reports were originally identified in a manufacturing-inspection form the FDA issued to Thoratec, after the FDA inspected California manufacturing plants. A company representative wasn't immediately available to answer questions about whether specific manufacturing issues were outlined in the inspection form or warning letter.