FDA 483 - Omega & Delta Co., Inc. - October 23, 2023

An FDA inspection of Omega & Delta Co., Inc. in Carolina, PR, a drug manufacturer, revealed significant deficiencies across its quality control unit and manufacturing operations. The firm lacked a functional quality control unit, failed to follow good documentation practices, and did not perform required annual product reviews or maintain proper sample storage. Additionally, the inspection noted issues with water system validation and a failure to adhere to its written stability testing program, with several observations being repeats from a previous inspection.