Ingenus Pharmaceuticals NJ, LLC. – FDA EIR, Dec 14, 2017

This FDA Pre-Approval Inspection of Ingenus Pharmaceuticals NJ, LLC, conducted from December 11 to December 14, 2017, assessed the company's readiness for an Abbreviated New Drug Application (ANDA) for generic solid oral dose products, under the regulatory framework of CPGM 7346.832. The inspection identified three main violations, documented on an FDA-483 form, requiring corrective actions. The first observation noted that deviations from written specifications were not properly recorded or justified (21 CFR 211.160(a)). Specifically, a validated Out of Specification (OOS) result for blend uniformity was not reported, with the company instead reporting an average from additional re-test samples. The FDA emphasized that all valid OOS results must be reported, and subsequent justifications handled separately. Secondly, laboratory controls were deficient because standard solutions for chromatographic analysis lacked verification with a second or check standard to ensure accuracy (21 CFR 211.160(b)). Management committed to implementing this verification for all chromatographic analyses. Lastly, test devices were found to be deficient; a dissolution apparatus (Q009) did not meet specified height requirements, and quality control analysts demonstrated inadequate knowledge in using the height check tool and adjusting paddle heights (21 CFR 211.160(b)(4)). The company's management promised immediate corrective actions for these instrument issues. Ingenus Pharmaceuticals NJ, LLC. is required to submit a written response detailing their corrective and preventive actions within 15 business days.