FDA inspection
Kalchem International, Inc.: FDA inspection ending Feb 21, 2020
FDA inspection 1121267 · Official Action Indicated (OAI) · Lindsay, OK
Key facts
| Inspection ID | 1121267 |
|---|---|
| Firm | Kalchem International, Inc. |
| FEI number | 1000149906 |
| Address | 224 S Main St Ste B |
| City | Lindsay |
| State | OK |
| ZIP | 73052 |
| Country | United States |
| Fiscal year | 2020 |
| Inspection end date | Feb 21, 2020 |
| Classification | Official Action Indicated (OAI) |
| Project area | Drug Quality Assurance |
| Product type | Drugs |
| Warning letter | 607098 |
At a glance
- None Citations
- 1–9 Posted citations
- Yes 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