FDA Inspection 831784 — MannKind Corporation
The FDA completed an inspection of MannKind Corporation on May 17, 2013 in Danbury, CT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 17, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Danbury, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |