FDA inspection
Kobayashi America Manufacturing, LLC: FDA inspection ending May 27, 2022
FDA inspection 1170436 · Official Action Indicated (OAI) · Dalton, GA
Key facts
| Inspection ID | 1170436 |
|---|---|
| Firm | Kobayashi America Manufacturing, LLC |
| FEI number | 3003079019 |
| Address | 245 Kraft Dr |
| City | Dalton |
| State | GA |
| ZIP | 30721 |
| Country | United States |
| Fiscal year | 2022 |
| Inspection end date | May 27, 2022 |
| Classification | Official Action Indicated (OAI) |
| Project area | Drug Quality Assurance |
| Product type | Drugs |
At a glance
- 1–9 Citations
- 1–9 Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- No Establishment inspection report (EIR) exists
- 1–9 Inspections at this FEI
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA inspections
FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.
Source: U.S. Food and Drug Administration (FDA), inspection classification data