FDA 483 - Azer Scientific, Inc. - December 04, 2023

An FDA inspection of Azer Scientific, Inc. in Morgantown, PA on December 4, 2023, revealed a significant deficiency in their quality system. The firm failed to adequately maintain complaint files, specifically lacking documented investigations for customer complaints involving foreign material and adverse events related to their glucose products. This indicates a serious lapse in their complaint handling procedures.