Drug factory · FDA FEI 3005191225

Nexus Pharmaceuticals, LLC

400 Knightsbridge Parkway, Lincolnshire, IL, United States

Problems found, fixed voluntarily at FDA's last inspection, Jun 4, 2026.

Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.

7 drug inspections on record since 2013: 2 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Ended	Result	Program	Problems noted
Jun 4, 2026	Problems found, fixed voluntarily	Drug Quality Assurance	7
Nov 7, 2023	No problems found	Bioresearch Monitoring	—
May 25, 2022	No problems found	Drug Quality Assurance	—
Jun 29, 2016	Problems found, fixed voluntarily	Drug Quality Assurance	1
Nov 5, 2014	Problems found, fixed voluntarily	Drug Quality Assurance	2
Mar 28, 2014	Problems found, fixed voluntarily	Drug Quality Assurance	1
Jan 16, 2013	Problems found, fixed voluntarily	Drug Quality Assurance	—

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

Written procedures describing in detail 21 CFR 211.122(a)
There is a lack of written procedures describing in sufficient detail the receipt, identification, storage, handling, sampling and examination of labeling and packaging materials.
Written records kept in individual logs 21 CFR 211.182
Written records of major equipment maintenance are not included in individual equipment logs.
Written record of investigation incomplete 21 CFR 211.192
Written records of investigations into unexplained discrepancies do not include the conclusions and follow-up.
Laboratory Test Method Verification 21 CFR 211.194(a)(2)
Verification of the suitability of the testing methods is deficient in that they are not performed under actual conditions of use.
Authority lacking to review records, investigate errors 21 CFR 211.22(a)
The quality control unit lacks authority to fully investigate errors that have occurred.
GMP Training Frequency 21 CFR 211.25(a)
GMP training is not conducted to assure that employees remain familiar with CGMP requirements applicable to them.
Backup data not assured as exact and complete 21 CFR 211.68(b)
Backup data is not assured as secure from alteration, erasure or loss through keeping hard copy or alternate systems.

Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.

Complaint Handling Procedure 21 CFR 211.198(a)
Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed.
Contract drug products--lack of responsibility 21 CFR 211.22(a)
The quality control unit lacks responsibility for approving or rejecting drug products under contract by another company.

Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine calibration, inspection, and checking of electronic equipment is not performed according to a written program designed to assure proper performance.

Registered with FDA for: analysis.