FDA 483 - Symed Labs Limited - October 16, 2021

An FDA inspection of Symed Labs Limited in Choutuppal, India, an Active Pharmaceutical Ingredient Intermediate Manufacturer, revealed significant deficiencies in equipment maintenance, laboratory controls, and computer system validation. Observations included leaking equipment with improper cleaning and inventory records, test methods lacking appropriate system suitability requirements, and the use of unvalidated software for critical chromatographic purity calculations. These issues raise concerns about the quality and purity of drug intermediates manufactured at the facility.