Curia New Jersey, LLCSeptember 21, 2023

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

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Record Details

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.

Company: Curia New Jersey, LLC
Inspection Date: September 21, 2023
Product Type: Drugs
Office: New Jersey District Office
Person: Janet A. Rajan (Investigator)

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ID · e17ac59c-b9aa-4b34-9ffb-99d238987c5a