WASHINGTON, June 28 (Reuters) - The U.S. Food and Drug Administration on Monday:
* released an agency letter to CSL Ltd following an April 2010 inspection, cited deviations from good manufacturing practices
* in letter to CSL Biotherapies, cited issues with its Parkville, Victoria facility in Australia that makes Afluria and influenza a (h1n1) monovalent vaccines
* said deviations at CSL Biotherapies plant include failure to investigate discrepancies or set testing procedures for ingredients, among other issues
* FDA posted the letter on its website at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ComplianceActivities/Enforcement/UntitledLetters/ucm217293.htm Keywords: CSL/ (Company news desk in Washington; +1 202 898 8400, washington.newsroom@thomsonreuters.com) COPYRIGHT Copyright Thomson Reuters 2010. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.
* released an agency letter to CSL Ltd following an April 2010 inspection, cited deviations from good manufacturing practices
* in letter to CSL Biotherapies, cited issues with its Parkville, Victoria facility in Australia that makes Afluria and influenza a (h1n1) monovalent vaccines
* said deviations at CSL Biotherapies plant include failure to investigate discrepancies or set testing procedures for ingredients, among other issues
* FDA posted the letter on its website at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ComplianceActivities/Enforcement/UntitledLetters/ucm217293.htm Keywords: CSL/ (Company news desk in Washington; +1 202 898 8400, washington.newsroom@thomsonreuters.com) COPYRIGHT Copyright Thomson Reuters 2010. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.
© 2010 AFX News
