Drug factory · FDA FEI 2245306
Guardian Drug Company, Inc.
2 Charles Court, Dayton, NJ, United States
No problems found at FDA's last inspection, Jan 16, 2026.
No Action Indicated: inspectors found no objectionable conditions.
9 drug inspections on record since 2008: 3 with no problems, 6 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Cholestyramine | Makes it | AiPing Pharmaceutical, Inc. | 11788-150 |
| Diatrizoic Acid | Makes it | Guardian Drug Company | 53041-688, 53041-690 |
| Furosemide | Makes it | Ipca Laboratories Limited | 83980-002, 83980-003, 83980-004 |
| Hydroxychloroquine | Makes it | Ipca Laboratories Limited | 83980-001 |
| Levetiracetam | Makes it | Guardian Drug Company | 53041-660 |
| Ondansetron | Makes it | Golden State Medical Supply, Inc. | 51407-003, 51407-004 |
| Potassium Cation | Makes it | Guardian Drug Company | 53041-420, 53041-680, 53041-681 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jan 16, 2026 | No problems found | Drug Quality Assurance | — |
| Nov 7, 2024 | No problems found | Bioresearch Monitoring | — |
| Feb 17, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 6, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 15, 2014 | No problems found | Drug Quality Assurance | — |
| Jun 8, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 2, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Feb 18, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Oct 28, 2008 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
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 2, 2012 inspection
- Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
Feb 18, 2011 inspection
- Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate standards designed to assure that conform to appropriate standards of identity, strength, quality and purity. - Lack of written stability program 21 CFR 211.166(a)
There is no written testing program designed to assess the stability characteristics of drug products. - Returned drug procedures in writing and followed 21 CFR 211.204
Procedures describing the of returned drug products are not followed. - Written procedures not established/followed 21 CFR 211.67(b)
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
Oct 28, 2008 inspection
- Written record of investigation incomplete 21 CFR 211.192
Written records of investigations into the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow-up.
Registered with FDA for: analysis; label; manufacture; pack.