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# Janssen Vaccines FDA-483
- URL: https://www.fdaweb.com/janssen-vaccines-fda-483/
- Published: 2025-02-25T12:00:00.000Z
- Updated: 2026-09-14T14:53:59.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5158716

FDA has released the form FDA-483 issued following an 11/11-11/19/2024 inspection at the firm’s vaccine manufacturing facility in Incheon, South Korea. The form’s specific inspection observations were:

- failure to have in writing and/or follow responsibilities and procedures for quality units to ensure the Field Alert Reports (Biological Product Deviations Reports) are submitted for the distributed products that are implicated with product quality issues;
- failure to establish or follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile;
- aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions;
- aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions; and
- equipment used in the manufacture, processing, packing, or holding of drug products is not of appropriate design to facilitate operations for its intended use.