Drug factory · FDA FEI 2010441
Kindeva Drug Delivery L.P.
19901 Nordhoff Street, Northridge, CA, United States
Problems found, fixed voluntarily at FDA's last inspection, Nov 13, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
12 drug inspections on record since 2009: 4 with no problems, 8 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Albuterol | Makes it, tests it, packages it and labels it | Merck Sharp & Dohme Corp., Sandoz Inc. | 0085-1132, 0781-7296 |
| Estradiol | Makes it | Bayer HealthCare Pharmaceuticals Inc. | 50419-451, 50419-452, 50419-453 +3 |
| Estradiol and Levonorgestrel | Makes it | Bayer HealthCare Pharmaceuticals Inc. | 50419-491 |
| Fentanyl | Makes it, tests it, packages it and labels it | Alvogen Inc. | 47781-423, 47781-424, 47781-426 +2 |
| Nitroglycerin | Makes it | Kindeva Drug Delivery L.P. | 0089-0171, 0089-0172, 0089-0173 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Nov 13, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Jul 28, 2021 | No problems found | Drug Quality Assurance | — |
| Jan 25, 2019 | No problems found | Drug Quality Assurance | — |
| Jan 25, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Mar 6, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Sep 1, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Sep 17, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Aug 23, 2013 | No problems found | Drug Quality Assurance | — |
| Jan 4, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 5, 2010 | No problems found | Drug Quality Assurance | — |
| Feb 12, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Feb 2, 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.
Nov 13, 2025 inspection
- Control procedures to monitor and validate performance 21 CFR 211.110(a)
Control procedures are not established which monitor the output and 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. - No written record of investigation 21 CFR 211.192
Written records are not always made of investigations into unexplained discrepancies.
Jan 25, 2019 inspection
- Failing drug products not rejected 21 CFR 211.165(f)
Drug products failing to meet established quality control criteria are not rejected. - 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.
Mar 6, 2017 inspection
- Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that conform to appropriate standards of identity, strength, quality and purity.
Sep 1, 2015 inspection
- Control procedures to monitor and validate performance 21 CFR 211.110(a)
Control procedures are not established which monitor the output and 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. - Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity. - Review of representative number of batches 21 CFR 211.180(e)(1)
Written procedures are not established for evaluations conducted at least annually to review records associated with a representative number of batches, whether approved or rejected.
Registered with FDA for: analysis; label; manufacture; pack; relabel; repack.