# FDA 483 - Curia New Mexico, LLC - December 07, 2016

Source: https://www.globalkeysolutions.net/records/483/curia-new-mexico-llc/78dab175-f882-4609-bebb-518d07ed4727

> FDA 483 for Curia New Mexico, LLC on December 07, 2016. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Curia New Mexico, LLC
- Inspection Date: 2016-12-07
- Product Type: drugs
- Office Name: Denver District Office
- Summary: Oso BioPharmaceuticals Manufacturing, LLC, a drug manufacturer in Albuquerque, NM, received two observations during an FDA inspection. The observations highlight deficiencies in laboratory controls, specifically regarding the lack of appropriate visual standards for particle identification in drug product vials, and issues with data integrity concerning the retention of true copies of analytical records. These findings indicate areas where the firm's practices do not fully comply with regulatory requirements.

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## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/gerard-t-schneider/47fd9b24-fe3e-4b58-a145-85a4c3b715de)
- [Haroon Vohra](https://www.globalkeysolutions.net/people/haroon-vohra/690c60b4-3059-4768-bfca-0cdabc58a72a)
- [Pharmaceutical Program Expert](https://www.globalkeysolutions.net/people/zachary-l-stamm/b729fab9-4d31-4c70-b5b3-e8b6207769c6)
- [Supervisory microbiologist](https://www.globalkeysolutions.net/people/zachery-l-miller/e7ff2001-1e81-4483-9e9b-288b7e92c719)

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