483
Sovereign Pharmaceuticals, LLCSovereign Pharmaceuticals, LLC – FDA 483, Dec 12, 2019
Record Details
Sovereign Pharmaceuticals, LLC in Fort Worth, TX was inspected and cited for significant quality system deficiencies. The firm's Quality Assurance unit failed to follow its own procedures, leading to the release of mislabeled drug product and inadequate investigations into discrepancies and customer complaints. Additionally, batch production records lacked complete labeling control records and documentation of quality checks.
View Company Profile
ID · c999f188-aeb5-47b4-a4fa-dea33076a0c4
Other documents for Sovereign Pharmaceuticals, LLC
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.