Home > Newsletters > FDAnews Drug Daily Bulletin > Incomplete Process Validation, Batch Failure Inquiries Spur Sovereign 483
FDAnews Drug Daily Bulletin
Sept. 27, 2012 | Vol. 9 No. 190
Incomplete Process Validation, Batch Failure Inquiries Spur Sovereign 483
Sovereign Pharmaceuticals’ blend uniformity tests and batch failure investigations fall short of the company’s written procedures, an FDA Form 483 states. Quality assurance personnel are responsible for reviewing and approving all aspects of process validation for solid oral dosage drugs produced at the company’s Fort Worth, Texas, facility.
Drug GMP Report
ePublishing :: CMS, Hosting & Web Development | © Copyright by FDAnewsAll rights reserved. Do not duplicate or redistribute in any form.