Drug factory · FDA FEI 3010164083
Bajaj Medical, LLC
415 W. Pershing Rd, Chicago, IL, United States
Problems found, fixed voluntarily at FDA's last inspection, Aug 25, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
4 drug inspections on record since 2015: 0 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Amantadine | Makes it, tests it, packages it and labels it | Bajaj Medical, LLC | 61037-484 |
| Cetirizine | Makes it, tests it, packages it and labels it | Bajaj Medical, LLC, Rising Pharma Holdings, Inc. | 61037-479, 16571-134 |
| Chlorhexidine | Makes it, tests it, packages it and labels it | Bajaj Medical, LLC, Rising Pharma Holdings, Inc. | 61037-469, 16571-128 |
| Lactulose | Makes it, tests it, packages it and labels it | Bajaj Medical, LLC, Rising Pharma Holdings, Inc. | 61037-471, 64980-592 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Aug 25, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Dec 4, 2024 | Problems found, fixed voluntarily | Bioresearch Monitoring | 1 |
| Oct 1, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Oct 16, 2015 | 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.
Aug 25, 2025 inspection
- Representative Samples Criteria 21 CFR 211.84(b)
The number of containers to be sampled is not based upon appropriate criteria.
Dec 4, 2024 inspection
- Failure to develop written procedures 21 CFR 314.80(b)
Written procedures have not been developed for the surveillance, receipt and evaluation of post marketing adverse drug experiences.
Oct 1, 2019 inspection
- Items to cover on annual reviews 21 CFR 211.180(e)(2)
Written procedures are not followed for evaluations done at least annually and including provisions for a review of complaints, recalls and returned or salvaged drug products.
Registered with FDA for: analysis; api manufacture; label; manufacture; pack; relabel; repack.