A complete response letter (CRL) from the FDA delays a product's entry to the market by an average of 14 months. Companies that receive the letters take an average of seven months just to respond to them. Imagine how much you could save if you could anticipate the FDA's concerns and address them before the agency issues the complete response letter? Now you can.
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