# FDA 483 - Curia New Mexico, LLC - April 11, 2022

Source: https://www.keypedia.com/records/483/curia-new-mexico-llc/f25fab27-c468-4106-a3eb-139d086b064c

> FDA 483 for Curia New Mexico, LLC on April 11, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Curia New Mexico, LLC
- Inspection Date: 2022-04-11
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Curia New Mexico, LLC, a sterile drug product manufacturer in Albuquerque, New Mexico, received a Form 483 with 13 observations following an FDA inspection. The observations highlight significant deficiencies across process validation, environmental monitoring for mold, investigation practices, aseptic processing, component identification, laboratory controls, microbial risk assessments, cleaning and sanitization programs, data integrity for electronic systems, utility qualification, equipment maintenance, and quality unit oversight of contractors. These issues indicate a broad lack of adequate controls to ensure the sterility, quality, and purity of drug products.

## Related Documents

- [483 - 2016-12-07](https://www.keypedia.com/records/483/curia-new-mexico-llc/78dab175-f882-4609-bebb-518d07ed4727)
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- [483 - 2024-06-28](https://www.keypedia.com/records/483/curia-new-mexico-llc/2073861b-35d0-477e-b598-529f53264a0b)

## Related Officers

- [Consumer Safety Officer (Drug Specialist)](https://www.keypedia.com/people/alan-p-kurtzberg/36ee316e-6d19-44b2-a131-fc254ada4f41)
- [James Brown, Ph.D.](https://www.keypedia.com/people/james-brown-phd/a07d87c2-9e03-4cfe-878c-908a0639acfa)
- [Zhong Li, Ph.D.](https://www.keypedia.com/people/zhong-li-phd/cf5baf58-da51-4387-922f-a5d281c07632)

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

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd