Drug factory · FDA FEI 1050658
Mikart, LLC
2090 Marietta Boulevard NW, Atlanta, GA, United States
No problems found at FDA's last inspection, Aug 10, 2026.
No Action Indicated: inspectors found no objectionable conditions.
30 drug inspections on record since 2009: 9 with no problems, 6 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Hydrocortisone | Makes it | Amneal Pharmaceuticals | 0115-1696, 0115-1697, 0115-1700 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Aug 10, 2026 | No problems found | Drug Quality Assurance | — |
| Aug 10, 2026 | No problems found | Drug Quality Assurance | — |
| Apr 26, 2022 | No problems found | Drug Quality Assurance | — |
| Apr 26, 2022 | No problems found | Drug Quality Assurance | — |
| Sep 8, 2021 | No problems found | Bioresearch Monitoring | — |
| Sep 8, 2021 | No problems found | Bioresearch Monitoring | — |
| Jan 18, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Jan 18, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Aug 23, 2018 | No problems found | Bioresearch Monitoring | — |
| Aug 23, 2018 | No problems found | Bioresearch Monitoring | — |
| Nov 16, 2017 | No problems found | Drug Quality Assurance | — |
| Nov 16, 2017 | No problems found | Drug Quality Assurance | — |
| May 3, 2016 | No problems found | Drug Quality Assurance | — |
| May 3, 2016 | No problems found | Drug Quality Assurance | — |
| Apr 23, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 23, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 5, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 5, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 20, 2011 | No problems found | Drug Quality Assurance | — |
| Jan 20, 2011 | No problems found | Drug Quality Assurance | — |
| Nov 12, 2010 | No problems found | Drug Quality Assurance | — |
| Nov 12, 2010 | No problems found | Drug Quality Assurance | — |
| Sep 29, 2010 | Problems found, fixed voluntarily | Bioresearch Monitoring | — |
| Sep 29, 2010 | Problems found, fixed voluntarily | Bioresearch Monitoring | — |
| Jun 16, 2010 | No problems found | Drug Quality Assurance | — |
| Jun 16, 2010 | No problems found | Drug Quality Assurance | — |
| Mar 9, 2009 | Problems found, fixed voluntarily | Postmarket Surv. and Epidemiology | — |
| Mar 9, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 9, 2009 | Problems found, fixed voluntarily | Postmarket Surv. and Epidemiology | — |
| Mar 9, 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.
Jan 18, 2019 inspection
- GMP Training Frequency 21 CFR 211.25(a)
GMP training is not conducted with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them. - GMP Training Frequency 21 CFR 211.25(a)
GMP training is not conducted with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them. - Quarantine Storage of Components 21 CFR 211.82(b)
Incoming components are not stored under quarantine until they have been tested or examined, as appropriate, and released. - Quarantine Storage of Components 21 CFR 211.82(b)
Incoming components are not stored under quarantine until they have been tested or examined, as appropriate, and released.
Registered with FDA for: manufacture.