Ingenus Pharmaceuticals NJ, LLC.December 14, 2017

FDA 483 - Ingenus Pharmaceuticals NJ, LLC. - December 14, 2017

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Record Details

Ingenus Pharmaceuticals NJ, LLC in Fairfield, NJ, a drug manufacturer, was inspected by the FDA from December 11-14, 2017. The inspection revealed significant deficiencies in laboratory controls, including improper handling of Out of Specification results, inadequate verification of standard solutions, and the use of test equipment that did not meet specifications. These issues indicate a lack of adherence to quality control procedures for drug product release.

Company: Ingenus Pharmaceuticals NJ, LLC.
Inspection Date: December 14, 2017
Product Type: Drugs
Office: New Jersey District Office
Person: Junho Pak (Investigator)

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ID · 21cba86e-7fa7-4b9f-8704-78ed9dd9ebe2