Drug factory · FDA FEI 3008436464
Xttrium Laboratories, Inc.
1200 E. Business Center Drive, Mount Prospect, IL, United States
Problems found, fixed voluntarily at FDA's last inspection, Jun 16, 2026.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
17 drug inspections on record since 2008: 6 with no problems, 9 with problems fixed voluntarily, 2 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Amantadine | Makes it | Xttrium Laboratories, Inc. | 0116-4010 |
| Chlorhexidine | Makes it | Benco Dental, Darby Dental Supply, LLC, Dentsply LLC. Professional Division Trading as "DENTSPLY Professional", Major Pharmaceuticals, McKesson Packaging Services Business Unit of McKesson Corporation, Xttrium Laboratories, Inc. | 66975-600, 66467-2560, 65222-800 +9 |
| Lactulose | Makes it | Xttrium Laboratories, Inc. | 0116-4005 |
| Lidocaine | Makes it, packages it and labels it | Xttrium Laboratories, Inc. | 0116-4027 |
| Nystatin | Makes it, packages it and labels it | Xttrium Laboratories, Inc. | 0116-4026 |
| Valproic Acid | Makes it, packages it and labels it | Xttrium Laboratories, Inc. | 0116-4021 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 16, 2026 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 18, 2025 | Serious problems, FDA action | Drug Quality Assurance | — |
| Mar 8, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 6, 2024 | No problems found | Bioresearch Monitoring | — |
| Mar 15, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Jul 11, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | 6 |
| May 25, 2016 | Problems found, fixed voluntarily | Bioresearch Monitoring | — |
| Dec 5, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Jan 15, 2013 | No problems found | Bioresearch Monitoring | — |
| Dec 11, 2012 | No problems found | Drug Quality Assurance | — |
| Oct 20, 2011 | No problems found | Drug Quality Assurance | — |
| Jul 18, 2011 | Problems found, fixed voluntarily | Postmarket Surv. and Epidemiology | — |
| Jul 18, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 16, 2010 | No problems found | Drug Quality Assurance | — |
| Feb 19, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Aug 20, 2009 | No problems found | Drug Quality Assurance | — |
| Dec 31, 2008 | Serious problems, FDA action | Drug Quality Assurance | 6 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Mar 15, 2018 inspection
- Procedures for non-sterile drug products 21 CFR 211.113(a)
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established and written.
Jul 11, 2016 inspection
- Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans and test procedures designed to assure that components and drug products conform to appropriate standards of identity, strength, quality and purity. - 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. - Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not cleaned and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product. - Cleaning SOPs/equipment protection 21 CFR 211.67(b)(5)
Procedures for the cleaning and maintenance of equipment are deficient regarding the protection of clean equipment from contamination prior to use. - Procedures To Be in Writing 21 CFR 211.80(a)
Written procedures are lacking which describe in sufficient detail the sampling, testing, approval and rejection of components, drug product containers and closures. - Representative Samples 21 CFR 211.84(b)
Representative samples are not taken of each shipment of each lot of components for testing or examination.
Dec 5, 2013 inspection
- Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not fully followed.
Feb 19, 2010 inspection
- Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed. - 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. - Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine calibration, inspection, and checking of automatic, mechanical, and electronic equipment is not performed according to a written program designed to assure proper performance.
Registered with FDA for: api manufacture; label; manufacture; pack.