FDA 483 - Syntec Pharma Corp - October 28, 2020

An FDA inspection of Syntec Pharma Corp. in Farmingdale, NY, revealed numerous significant deficiencies in their API repacking and relabeling operations. The firm failed to adequately separate hazardous materials, lacked validated cleaning procedures, and operated without an established quality unit. These critical issues indicate a severe lack of control over product quality, increasing the risk of cross-contamination and compromised drug integrity.