Drug factory · FDA FEI 2242829
LTS Lakewood, LLC
1200 Paco Way, Lakewood, NJ, United States
Problems found, fixed voluntarily at FDA's last inspection, Jul 29, 2026.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
14 drug inspections on record since 2009: 6 with no problems, 7 with problems fixed voluntarily, 1 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Collagenase Clostridium Histolyticum | Makes it, tests it and packages it | Smith & Nephew, Inc | 50484-010 |
| Esketamine | Makes it, tests it and packages it | Janssen Pharmaceuticals, Inc. | 50458-028 |
| Fentanyl | Makes it, packages it and labels it | West Therapeutic Development LLC | 71500-110, 71500-130, 71500-140 |
| Sumatriptan | Makes it and tests it | Promius Pharma, LLC., Upsher-Smith Laboratories, LLC | 67857-812, 0245-0812 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jul 29, 2026 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Jun 6, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 22, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 15, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 26, 2017 | No problems found | Drug Quality Assurance | — |
| Jun 1, 2016 | No problems found | Drug Quality Assurance | — |
| Feb 6, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 4, 2014 | No problems found | Drug Quality Assurance | — |
| Jan 17, 2013 | No problems found | Drug Quality Assurance | — |
| Mar 7, 2012 | Serious problems, FDA action | Drug Quality Assurance | 1 |
| Aug 10, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Jun 15, 2010 | No problems found | Drug Quality Assurance | — |
| Apr 28, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Nov 3, 2009 | No problems found | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Jul 29, 2026 inspection
- Absence of Written Procedures 21 CFR 211.100(a)
Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
Mar 7, 2012 inspection
- Validation lacking for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of the sterilization process.
Aug 10, 2011 inspection
- Control procedures to monitor and validate performance 21 CFR 211.110(a)
Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product. - Test methods 21 CFR 211.165(e)
The accuracy, sensitivity, specificity, and reproducibility of test methods have not been established. - 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.
Apr 28, 2010 inspection
- Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review 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. - Failure to meet specifications 21 CFR 314.81(b)(1)(ii)
An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning a failure of one or more distributed batches of a drug to meet the specifications established for it in the application.
Registered with FDA for: analysis; label; manufacture; pack.