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# Isorx FDA-483 Released
- URL: https://www.fdaweb.com/isorx-fda-483-released/
- Published: 2019-11-13T12:00:00.000Z
- Updated: 2026-09-14T15:53:04.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145493

FDA has released the FDA-483 issued following a 9/1-9/18 agency inspection at Isorx Corp., a Richmond, CA, producer of sterile and non-sterile drugs. The four inspection [observations](https://www.fda.gov/media/132341/download?ref=fdaweb.com) were: 

- failing to disinfect materials or supplies before entering the aseptic processing areas;
- disinfecting agents and cleaning wipes used in the ISO 5 classified aseptic processing areas were not sterile;
- failing to use sporicidal agents in the facility’s clean rooms and/or ISO 5 classified aseptic processing areas; and
- failing to prepare batch production and control records for each batch of drug products produced and failing to include complete information relating to the production and control of each batch.