> ## 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.

# 2 Observations in OSO Biopharmaceuticals FDA-483
- URL: https://www.fdaweb.com/2-observations-in-oso-biopharmaceuticals-fda-483/
- Published: 2021-01-04T12:00:00.000Z
- Updated: 2026-09-14T16:41:19.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148368

FDA has released the FDA-483 issued following a 3/16-3/20/20 inspection at OSO Biopharmaceuticals Manufacturing, an Albuquerque, NM, parenteral drug manufacturer. The two inspection observations were: 

- failing to establish procedures designed to prevent microbiological contamination of drug products purporting to be sterile; and
- failure of written records of investigations into unexplained discrepancies to always include the conclusions and follow-up.