FDA 483 - Bio-Thera Solutions, Ltd. - September 26, 2025

Luitpold Pharmaceuticals, Inc., a drug manufacturer in Shirley, NY, was subject to an FDA inspection from September 11 to October 6, 2017. The inspection revealed multiple critical deficiencies in the company's manufacturing and quality control systems, indicating non-compliance with current Good Manufacturing Practice regulations.

Key violations included a systemic failure to thoroughly investigate unexplained discrepancies and product failures. Specifically, investigations into sub-potent drug complaints (e.g., Adequan, Acetylcysteine Solution) and foreign matter (glass particles in Adequan vials) were found to be inadequate, lacking proper root cause identification or scope expansion. The quality control unit also failed to establish and validate manual inspection processes for visible particles, with no clear specifications for particle size, number, or identity in finished products. Additionally, employees tasked with visual inspection of vials were inadequately trained to detect glass particles, lacking necessary test kits and effectiveness verification. Lastly, equipment cleaning procedures, particularly for the vial washer, were insufficient, contributing to instances of glass delamination.

To address these observations, Luitpold Pharmaceuticals is required to implement comprehensive corrective and preventative actions. These actions must include improving investigation protocols, validating visual inspection processes with established specifications, enhancing employee training, and updating equipment cleaning and maintenance procedures to ensure product quality, purity, and patient safety.