FDA 483 - Nubratori, Inc - December 01, 2025

An FDA inspection of Nubratori, Inc., an outsourcing facility in Torrance, CA, was conducted from December 1-11, 2025, revealing several critical deficiencies in its manufacturing processes. The Food and Drug Administration issued a Form FDA 483 outlining three primary observations.First, the company"s written procedures for equipment cleaning and maintenance were inadequate. Cleaning validation studies from 2017 were found to be insufficient, as they relied on media fills rather than actual drug product residues and failed to scientifically justify worst-case product selections. A cleaning verification activity in 2025 was also deemed inadequate without prior comprehensive validation.Second, Nubratori, Inc. lacked sufficient written procedures for production and process controls. The firm modified vial filling configurations for sterile injectable products, including Lidocidex I and Lidomar, in 2023 without performing appropriate process validation studies. Instead, it inadequately used media fill studies, raising concerns about ensuring the identity, strength, purity, and quality of drug products.Third, procedures designed to prevent microbiological contamination of sterile drug products were not adequately established. Smoke studies from 2024 did not accurately represent actual operating conditions, particularly regarding the preparation and placement of environmental monitoring plates. Inspectors observed personnel introducing non-sterile items and disrupting critical unidirectional airflow within sterile hoods during compounding, which increased the risk of contamination.Nubratori, Inc. is required to address these inspectional observations by developing and implementing comprehensive corrective and preventive actions to ensure compliance with regulatory standards for sterile drug manufacturing.