# FDA 483 - Curia New Jersey, LLC - September 21, 2023

Source: https://www.keypedia.com/records/483/curia-new-jersey-llc/e17ac59c-b9aa-4b34-9ffb-99d238987c5a

> FDA 483 for Curia New Jersey, LLC on September 21, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Curia New Jersey, LLC
- Inspection Date: 2023-09-21
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Curia New Jersey, LLC's Control Laboratory in Lebanon, NJ, identified a significant issue regarding the absence of critical testing equipment. The firm failed to follow established test procedures because X-Ray Powder Diffraction (XRPD) equipment, necessary for testing drug substance polymorphic forms at release and during stability, was not available on site. This indicates a serious deficiency in quality control and laboratory operations.

## Related Officers

- [Investigator](https://www.keypedia.com/people/janet-a-rajan/95741927-9a4d-422b-bd51-01783d962cbe)

Company: https://www.keypedia.com/companies/curia-new-jersey-llc/3487be34-bea7-4920-8489-0c360d8868f0

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248