Drug factory · FDA FEI 3005340341
Mannkind Corporation
1 Casper St, Danbury, CT, United States
No problems found at FDA's last inspection, Nov 4, 2025.
No Action Indicated: inspectors found no objectionable conditions.
5 drug inspections on record since 2009: 2 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Insulin Human | Makes it, tests it, packages it and labels it | Mannkind Corporation | 47918-874, 47918-878, 47918-880 +4 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Nov 4, 2025 | No problems found | Drug Quality Assurance | — |
| Aug 6, 2021 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 19, 2018 | No problems found | Drug Quality Assurance | — |
| May 17, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Dec 4, 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.
May 17, 2013 inspection
- Actual vs. theoretical yields not determined 21 CFR 211.103
Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate phase of manufacturing of the drug product. - Extent of discrepancy, failure investigations 21 CFR 211.192
Investigations of a failure of a batch or any of its components to meet any of its specifications did not extend to other batches of the same drug product.
Registered with FDA for: analysis; label; manufacture; pack.