FDA 483 - LTS Lohmann Therapy Systems Corp - June 11, 2019

During an inspection, LTS Lohmann Therapy Systems Corp in West Caldwell, NJ, was cited for significant deficiencies in their quality system and laboratory controls. The firm failed to thoroughly investigate out-of-specification results and lacked statistical justification for batch release. Additionally, inadequate controls over computer systems, including disabled audit trails and unauthorized access, compromised data integrity.