# FDA 483 - Curia New Mexico, LLC - March 20, 2020

Source: https://www.globalkeysolutions.net/records/483/curia-new-mexico-llc/adb16b59-3aa2-4e64-8afb-c1107dc30d59

> FDA 483 for Curia New Mexico, LLC on March 20, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Curia New Mexico, LLC
- Inspection Date: 2020-03-20
- Product Type: drugs
- Office Name: Denver District Office
- Summary: OSO BioPharmaceuticals Manufacturing, LLC (AMRI) in Albuquerque, NM, a parenteral drug manufacturer, was cited for two observations. The inspection revealed significant deficiencies in procedures designed to prevent microbiological contamination of sterile drug products and in the completeness of investigation records for unexplained discrepancies, including particle and insect contamination. These issues indicate a moderate to severe risk to product quality and patient safety.

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## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/michael-a-charles/f83241f0-ae3b-4535-ac03-e790bbf666ca)

Company: https://www.globalkeysolutions.net/companies/curia-new-mexico-llc/f4d321d8-f0a6-4af6-b5d1-ad96f12425ae

Office: https://www.globalkeysolutions.net/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face