Drug factory · FDA FEI 3001611969
Leading Pharma, LLC
3 Oak Rd, Fairfield, NJ, United States
Problems found, fixed voluntarily at FDA's last inspection, Oct 21, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
13 drug inspections on record since 2009: 3 with no problems, 10 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Atropine and Diphenoxylate | Makes it, tests it and packages it | Leading Pharma, LLC | 69315-910 |
| Benztropine | Makes it | Leading Pharma, LLC | 69315-136, 69315-137, 69315-138 |
| Carbinoxamine | Makes it | Leading Pharma, LLC | 69315-239 |
| Clomipramine | Makes it | Leading Pharma, LLC | 69315-165, 69315-166, 69315-167 |
| Folic Acid | Makes it | Leading Pharma, LLC | 69315-127 |
| Furosemide | Makes it | Leading Pharma, LLC | 69315-116, 69315-117, 69315-118 |
| Glycopyrronium | Makes it | Leading Pharma, LLC | 69315-139, 69315-140 |
| Hydrochlorothiazide | Makes it | Leading Pharma, LLC | 69315-130, 69315-131, 69315-155 |
| Imipramine | Makes it | Leading Pharma, LLC | 69315-133, 69315-134, 69315-135 |
| Leucovorin | Makes it | Leading Pharma, LLC | 69315-184, 69315-185, 69315-186 +1 |
| Lorazepam | Makes it | Leading Pharma, LLC | 69315-904, 69315-905, 69315-906 |
| Oxazepam | Makes it | Leading Pharma, LLC | 69315-911, 69315-912, 69315-913 |
| Prochlorperazine | Makes it | Leading Pharma, LLC | 69315-265, 69315-266 |
| Theophylline | Makes it | Leading Pharma, LLC | 69315-226, 69315-227 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Oct 21, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | 5 |
| Aug 11, 2020 | No problems found | Bioresearch Monitoring | — |
| Jan 31, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 31, 2018 | No problems found | Drug Quality Assurance | — |
| Apr 14, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Apr 14, 2017 | Problems found, fixed voluntarily | Bioresearch Monitoring | 4 |
| Mar 10, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 6, 2015 | Problems found, fixed voluntarily | Bioresearch Monitoring | — |
| Jun 12, 2013 | Problems found, fixed voluntarily | Postmarket Surv. and Epidemiology | — |
| Jun 12, 2013 | No problems found | Drug Quality Assurance | — |
| Jan 23, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 6, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 8, 2009 | Problems found, fixed voluntarily | 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.
Oct 21, 2024 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. - In-process materials characteristics testing 21 CFR 211.110(c)
In-process materials are not tested for quality and approved or rejected by the quality control unit after storage for long periods. - Test methods 21 CFR 211.165(e)
The accuracy, sensitivity, specificity and reproducibility of test methods have not been established and documented. - 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. - Computer control of master formula records 21 CFR 211.68(b)
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
Apr 14, 2017 inspection
- Failure to report non-alert ADEs 21 CFR 314.80(c)(2)
Individual ADEs which were not reported to FDA in a post marketing 15-day alert have not been included in a periodic safety report. - Failure to report non-alert ADEs 21 CFR 314.80(c)(2)
Individual ADEs which were not reported to FDA in a post marketing 15-day alert have not been included in a periodic safety report. - 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. - 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; manufacture; pack.