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# Nanchang Anobri FDA-483 Released
- URL: https://www.fdaweb.com/nanchang-anobri-fda-483-released/
- Published: 2024-10-10T12:00:00.000Z
- Updated: 2026-09-14T14:43:38.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157953

FDA has released the eight-page form FDA-483 issued following an 11/13-11/21/2023 inspection at the Nanchang Anobri drug product manufacturing facility in Nanchang City, China. The 12 inspection [observations](http://www.fda.gov/media/182557/download?ref=fdaweb.com) were:

- failure to fully follow the quality control unit’s applicable policies and procedures;
- failure to follow established test procedures and laboratory control mechanisms;
- failure of laboratory controls to include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality, and purity;
- failure to handle and store components at all times in a manner to prevent contamination;
- failure of batch production and control records to include complete information relating to the production and control of each batch;
- procedures for the cleaning and maintenance of equipment are deficient regarding assignment of responsibility for cleaning and maintaining equipment;
- failure to establish design plans that describe or reference the design and development activities and design responsibility for implementation;
- failure to adequately establish procedures for design output;
- failure to adequately establish procedures for quality audits;
- failure to adequately establish procedures for monitoring and control of process parameters for a validated process;
- failure to establish and maintain document control procedures; and
- failure to adequately establish procedures for training and identifying training needs.