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# Fusion IV Pharmaceuticals FDA-483
- URL: https://www.fdaweb.com/fusion-iv-pharmaceuticals-fda-483/
- Published: 2020-03-13T12:00:00.000Z
- Updated: 2026-09-14T16:07:04.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146323

FDA has released the FDA-483 issued following a 12/2-12/20/19 inspection at Fusion IV Pharmaceuticals (Axia Pharmaceutical), a Los Angeles, CA, producer of sterile drug products. The inspection observations were: 

- failing to maintain buildings used in the manufacture, processing, packing, or holding of drug products in a clean and sanitary condition;
- failing to follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile;
- failing 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;
- failing to train employees in the particular operation they perform as part of their function, current good manufacturing practices, and written procedures required by current good manufacturing practice regulations;
- failing to have laboratory controls include the establishment of scientifically sound and appropriate test procedures designed to assure that \[they\] 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;
- failing to document in the batch production records examination of packaging and labeling materials for suitability and correctness before packaging operations; and
- failing to laboratory test each batch of drug product purporting to be sterile and pyrogen-free to determine conformance to such requirements.