OSRX Inc.September 23, 2021

FDA 483 - OSRX Inc. - September 23, 2021

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Record Details

OSRX, Inc. dba Pinnacle Compounding in Missoula, MT, a producer of sterile drug products, was inspected by the FDA. The inspection revealed a significant concern regarding the firm's laminar airflow studies (smoke studies). These studies were found not to be representative of current aseptic compounding practices, failing to simulate critical operations and interventions used during sterile drug production.

Company: OSRX Inc.
Inspection Date: September 23, 2021
Product Type: Drugs
Office: Division of Human and Animal Food Operations - West VI
People: Kenneth O. Gee (Consumer Safety Officer)
Sangeeta M. Khurana (Consumer Safety Officer)

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ID · 8b8c2491-c4fa-4446-842d-b3703af5f421