FDA 483 - Divi's Laboratories Ltd. (Unit II) - July 19, 2024

During an inspection conducted by the U.S. Food and Drug Administration (FDA) from July 11 to July 19, 2024, Divi's Laboratories Ltd. (Unit II) in Visakhapatnam, India, received a Form FDA 483 detailing an observation. The inspection was conducted at their Active Pharmaceutical Ingredient (API) manufacturing facility. The primary observation noted that written procedures for cleaning equipment used in API manufacturing were not adequately established. Specifically, the company's Standard Operating Procedure for cleaning procedures (SOP NO: PD/OP/0017) lacked specific provisions. It did not include instructions for cleaning or visually inspecting the area behind certain components of the equipment utilized in the production of APIs. This indicates a gap in the firm's quality management system concerning facilities and equipment cleanliness. As an inspectional observation, this document does not represent a final determination of compliance. However, Divi's Laboratories Ltd. is expected to address this observation by either discussing any objections or by implementing and submitting comprehensive corrective actions to the FDA. Such actions are crucial to ensure adherence to good manufacturing practices and maintain product quality and safety.