FDA EIR - Sovereign Pharmaceuticals, LLC - December 12, 2019

Sovereign Pharmaceuticals, LLC underwent an FDA cGMP inspection at its Fort Worth, TX facility from December 4 to December 12, 2019. This inspection, conducted under Compliance Program 7356.002 for Drug Manufacturing, revealed three significant findings. The Quality Control Unit failed to follow its written procedures, specifically by approving and distributing mislabeled Acetaminophen/Hydrocodone Bitartrate liquid bulk product due to errors in batch production records that were not caught by Quality Assurance. A repeat observation concerned the company's failure to thoroughly investigate unexplained discrepancies, including an inadequate investigation into the mislabeled product that did not address Quality Assurance or Quality Inspector accountability, and an insufficient response to a product complaint without reviewing retain samples. Furthermore, batch production records were deficient, lacking complete labeling control records, specimens, and copies of labeling for bulk liquid products. These issues indicated non-compliance with good manufacturing practice regulations. Company management acknowledged the observations and committed to providing a written response with proposed corrections to the FDA within 15 business days. The firm also initiated minor facility repairs during the inspection.