Home > Newsletters > FDAnews Drug Daily Bulletin > Scientific Protein Laboratories Gets Form 483 for Heparin Plant
FDAnews Drug Daily Bulletin
May 13, 2009 | Vol. 6 No. 93
Scientific Protein Laboratories Gets Form 483 for Heparin Plant
There were several incidents in which personnel at Scientific Protein Laboratories signed off on incorrect or inadequate data and reports, calling into question the company’s management review of production operations, according to a recent FDA Form 483. The FDA inspector cited six inspection observations at the company’s plant in Waunakee, Wis. Two of the most recent annual product reviews failed to report all deviations, and change control documentation did not reference supportive data but was approved by management, according to the Form 483.
Drug GMP Report
ePublishing :: CMS, Hosting & Web Development | © Copyright by FDAnewsAll rights reserved. Do not duplicate or redistribute in any form.