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. But an agency review of process validation reports found that blend uniformity tests were not conducted for replicate samples from different locations in respective blenders, the form states.
Drug GMP Report