FDA 483 - LTS Therapy Systems, LLC - September 30, 2025

An FDA inspection of LTS Therapy Systems LLC in Saint Paul, MN, a drug manufacturer, revealed significant deficiencies across multiple quality system areas. The firm failed to thoroughly investigate manufacturing discrepancies, maintain adequate laboratory controls including data integrity, and establish sound production and process control procedures. Additionally, the quality control unit's responsibilities and procedures were found to be inadequate, indicating a broad lack of adherence to cGMP requirements.