> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Eight Observations in Fusion IV FDA-483
- URL: https://www.fdaweb.com/eight-observations-in-fusion-iv-fda-483/
- Published: 2017-06-01T12:00:00.000Z
- Updated: 2026-09-14T22:26:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138836

FDA has released the [FDA-483](https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-orgs/documents/document/ucm558260.pdf?ref=fdaweb.com) issued following its 3/3-3/23 inspection at Fusion IV Pharmaceuticals, Los Angeles, CA, a producer of sterile drug products. Observations were: 

- failing to establish procedures designed to prevent microbiological contamination of drug products purporting to be sterile;
- · failing to have procedures designed to prevent microbiological contamination of drug products purporting to be sterile to include adequate validation of the sterilization process;
- failing to sterilize and process drug product containers and closures to remove pyrogenic properties to assure they are suitable for their intended use;
- · deficiency in aseptic processing areas regarding the system for monitoring environmental conditions;
- failing to test through appropriate laboratory testing each batch of drug product required to be free of objectionable microorganisms;
- deficient labels of the outsourcing facility’s drug products;
- failing to exercise strict control over labeling issued for use in drug product labeling operations; and
- failing to submit to FDA an outsourcing facility initial report identifying products compounded during the previous six months.