# FDA 483 - Curia New Mexico, LLC - June 28, 2024

Source: https://www.keypedia.com/records/483/curia-new-mexico-llc/2073861b-35d0-477e-b598-529f53264a0b

> FDA 483 for Curia New Mexico, LLC on June 28, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Curia New Mexico, LLC
- Inspection Date: 2024-06-28
- Product Type: drugs
- Office Name: Denver District Office
- Summary: An FDA inspection of Curia New Mexico, LLC, a sterile drug manufacturer in Albuquerque, NM, revealed significant deficiencies in aseptic processing. Observations included unvalidated hold times for environmental monitoring samples, a lack of required testing for Grade A filling lines, and improper personnel monitoring procedures, indicating potential risks to product sterility.

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## Related Officers

- [Senior CSO, Investigator](https://www.keypedia.com/people/nicholas-l-hunt/2f10c080-c02e-4cc3-a8a0-0675b9c4cc6d)
- [Carolina D. Vasquez](https://www.keypedia.com/people/carolina-d-vasquez/ffa9d542-e660-4575-831e-f11a2de4b978)

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

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