FDA 483 - Dr. Reddy's Laboratories New York, Inc. - March 03, 2021

An FDA inspection of Dr. Reddy's Laboratories New York, Inc. in Middleburgh, NY, an Active Pharmaceutical Ingredient (API) Manufacturer, revealed significant deficiencies in equipment cleaning procedures and batch record documentation. The firm failed to establish detailed cleaning procedures with measurable endpoints, lacked cleaning validation studies for major equipment, and did not properly record equipment identification in batch records. These issues indicate a lack of adequate controls over manufacturing processes.