LTS Lohmann Therapy Systems Corp – FDA EIR, Jun 11, 2019

An unannounced Good Manufacturing Practices (GMP) surveillance inspection of LTS Lohmann Therapy Systems Corp. in West Caldwell, NJ, was conducted by the FDA from June 4 to June 11, 2019. The inspection, focusing on drug manufacturing and quality sampling under the Food Drug and Cosmetic Act, covered the company's operations as a contract transdermal and thin film manufacturer, including opioid products. At the inspection's conclusion, a Form FDA 483 was issued, detailing two significant observations. Firstly, the firm failed to thoroughly review unexplained discrepancies and batch failures to meet specifications, with investigations into out-of-specification results lacking adequate root cause identification and statistical justification for batch release. Secondly, appropriate controls were not exercised over computer systems, specifically HPLC systems, to ensure data integrity and restrict changes to authorized personnel; issues included disabled audit trails for commercial products and the use of system administrator logins without sufficient safeguards against data alteration. LTS Lohmann Therapy Systems' CEO acknowledged the observations and committed to implementing corrective actions, with a comprehensive response due to the FDA within 15 business days.