FDA inspection
ALK-Abello, Inc: FDA inspection ending Oct 17, 2003
FDA inspection 300528 · No Action Indicated (NAI) · Round Rock, TX
Key facts
| Inspection ID | 300528 |
|---|---|
| Firm | ALK-Abello, Inc |
| FEI number | 1640000 |
| Address | 1700 Royston Ln |
| City | Round Rock |
| State | TX |
| ZIP | 78664-9555 |
| Fiscal year | 2004 |
| Inspection end date | Oct 17, 2003 |
| Classification | No Action Indicated (NAI) |
| Project area | Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic Products|Vaccines and Allergenic 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| Product type | Biologics, Drugs |
At a glance
- None Citations
- None 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