FDA 483 - Allied Pharmacy Products. Inc. - March 13, 2019

An FDA inspection of ALLIED PHARMACY PRODUCTS, INC. in Hicksville, NY, from March 11-13, 2019, revealed a significant quality system deficiency. The firm failed to establish a design history file for multiple Steri-Tamp seal products. This indicates a lack of proper documentation for the design and development of their medical devices.