Nexus Pharmaceuticals, LLCNovember 5, 2014

FDA 483 - Nexus Pharmaceuticals, LLC - November 05, 2014

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Nexus Pharmaceuticals Inc. in Vernon Hills, IL, was inspected regarding its role as a drug product owner and ANDA applicant holder. The inspection revealed significant deficiencies in the firm's quality control unit responsibilities for contract manufacturing and its procedures for handling drug product complaints. These issues indicate a lack of adequate oversight and investigation into product quality concerns.

Company: Nexus Pharmaceuticals, LLC
Inspection Date: November 5, 2014
Product Type: Drugs
Office: Chicago District Office
Person: Christina A. Miller (Senior Compliance Manager)

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ID · 98f2e2a3-d907-4230-9890-b8528ea9abf0