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FDA establishment 3005191225, Lincolnshire, Illinois, United States. Part of Nexus Pharmaceuticals's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 7
Official action indicated: 0
Last inspection ended: Jun 4, 2026
Warning letters: 0
Inspections by Fiscal Year
FY2018 to FY2027 to date; 0 classified OAI
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
21 CFR 211.25(a). GMP Training Frequency GMP training is not conducted to assure that employees remain familiar with CGMP requirements applicable to them.
21 CFR 211.182. Written records kept in individual logs Written records of major equipment maintenance are not included in individual equipment logs.
21 CFR 211.194(a)(2). Laboratory Test Method Verification Verification of the suitability of the testing methods is deficient in that they are not performed under actual conditions of use.
21 CFR 211.122(a). Written procedures describing in detail There is a lack of written procedures describing in sufficient detail the receipt, identification, storage, handling, sampling and examination of labeling and packaging materials.
21 CFR 211.22(a). Authority lacking to review records, investigate errors The quality control unit lacks authority to fully investigate errors that have occurred.
21 CFR 211.68(b). Backup data not assured as exact and complete Backup data is not assured as secure from alteration, erasure or loss through keeping hard copy or alternate systems.
21 CFR 211.192. Written record of investigation incomplete Written records of investigations into unexplained discrepancies do not include the conclusions and follow-up.
Voluntary Action Indicated (VAI)
Nov 7, 2023
Drugs · Bioresearch Monitoring
None posted
No Action Indicated (NAI)
May 25, 2022
Drugs · Drug Quality Assurance
None posted
No Action Indicated (NAI)
Jun 29, 2016
Drugs · Drug Quality Assurance
1 cited reference
21 CFR 211.22(d). Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Voluntary Action Indicated (VAI)
Nov 5, 2014
Drugs · Drug Quality Assurance
2 cited references
21 CFR 211.198(a). Complaint Handling Procedure Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed.
21 CFR 211.22(a). Contract drug products--lack of responsibility The quality control unit lacks responsibility for approving or rejecting drug products under contract by another company.
Voluntary Action Indicated (VAI)
Mar 28, 2014
Drugs · Drug Quality Assurance
1 cited reference
21 CFR 211.68(a). Calibration/Inspection/Checking not done Routine calibration, inspection, and checking of electronic equipment is not performed according to a written program designed to assure proper performance.
An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. Recalls come from FDA's enforcement reports (iRES), one row per recall even when it covers many lots. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm.FDA Data Dashboard, warning letters and enforcement reports
Lincolnshire, Illinois, United States. Part of