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

An unnamed pharmaceutical firm received an FDA Form 483 following an inspection on September 30, 2025, detailing significant issues with its manufacturing and quality control systems. The observations indicate a failure to comply with current Good Manufacturing Practices (GMPs) as outlined under the Federal Food, Drug, and Cosmetic Act.

Key violations include the firm's inadequate investigation into approximately 18 assay and impurity failures, and out-of-trend results across multiple batches, often lacking robust corrective actions. Laboratory controls were found deficient, specifically regarding data integrity with an absence of raw data review for critical equipment, alterable system clocks, and unvalidated water testing methods. Furthermore, the firm failed to establish adequate written procedures for production and process controls, evidenced by scientifically unsound process validation studies, late documentation of production discrepancies, and a lack of clear requirements for manufacturing alarms. Finally, the quality control unit did not consistently follow written procedures, failing to place validation batches on stability studies after product failures and using scientifically unjustified yield calculations.

To address these observations, the firm is required to implement comprehensive corrective and preventive actions to ensure thorough investigations, robust laboratory data integrity, validated processes, and compliant quality control procedures, thereby safeguarding product quality, strength, and purity.