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# FDA-483 from OSRX Inspection
- URL: https://www.fdaweb.com/fda-483-from-osrx-inspection/
- Published: 2022-03-01T12:00:00.000Z
- Updated: 2026-09-14T17:34:44.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151257

FDA has released the FDA-483 issued following a 9/15-9/23/21 inspection at OSRX, Inc., a Missoula, MT, producer of sterile drug products. The [form](https://www.fda.gov/media/156389/download?ref=fdaweb.com) contains one observation that the current laminar airflow studies (smoke studies) of the ISO5 laminar airflow workstation were not performed under conditions showing aseptic operations that are representative of the firm’s current compounding practices nor did they emulate all critical unit operations and interventions used during compounding of sterile drug products.