FDA 483 - Alden Medical LLC - April 23, 2019

Alden Medical LLC, a pharmaceutical manufacturer in W Springfield, MA, was inspected by the FDA from April 10-23, 2019. The inspection revealed significant deficiencies across multiple areas of their manufacturing and quality control processes for hand sanitizer products, including the use of expired active pharmaceutical ingredients, inadequate component testing, and a lack of proper validation for laboratory methods, cleaning procedures, and manufacturing processes. These issues indicate a systemic failure to adhere to current good manufacturing practices, posing a risk to product quality and safety.