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# 3-year-old Fusion IV FDA-483 Released
- URL: https://www.fdaweb.com/3-year-old-fusion-iv-fda-483-released/
- Published: 2024-03-28T12:00:00.000Z
- Updated: 2026-09-14T14:26:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156654

FDA has released the form FDA-483 issued following a 12/2-12/20/2019 inspection at the Fusion IV Pharmaceuticals outsourcing facility doing business as Axia Pharmaceutical in Los Angeles, CA. The form contained these nine inspection observations:

- buildings used in the manufacture, processing, packing, or holding of drug products are not maintained in a clean and sanitary condition;
- failure to follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile;
- failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has already been distributed;
- employees are not given training in the particular operations they perform as part of their function, current good manufacturing practices and written procedures required by current good manufacturing practice regulations;
- laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that conform to appropriate standards of identity, strength, quality, and purity;
- the quality control unit lacks authority to fully investigate errors that have occurred;
- aseptic processing areas are deficient regarding the system for monitoring environmental conditions;
- examination of packaging and labeling materials for suitability and correctness before packaging operations is not documented in the batch production records; and
- each batch of a drug product purporting to be sterile and pyrogen-free is not laboratory tested to determine conformance to such requirements.