FDA 483 - Acino Products, LLC - August 30, 2024

Acino Products, LLC, a drug manufacturer in Trenton, NJ, was inspected and found to have significant deficiencies across its operations. The inspection revealed a severe lack of validated processes, inadequate quality control procedures, unsanitary conditions in a residential garage used for drug packaging and storage, and insufficient testing for product stability and microbial contamination. Many of these issues were repeat observations from previous inspections, indicating a systemic failure to adhere to GMP regulations.