Warning letter
ALK-Abello Inc.: warning letter of Mar 16, 2000
FDA warning letter UCM068247 · Center for Biologics Evaluation and Research
Key facts
| Reference number | UCM068247 |
|---|---|
| Company | ALK-Abello Inc. |
| Subject | Allergenic Extracts/Good Manufacturing Practices/Biologicals Standards Products |
| Issue date | Mar 16, 2000 |
| Posted date | Mar 16, 2000 |
| Issuing office | Center for Biologics Evaluation and Research |
| Product type | Biologics |
| CFR sections cited | 2, 211, 211.160 |
| Country | 3 |
| Inspection city | Round Rock |
| Inspection ZIP | 78664-9555 |
| Inspection start date | Oct 18, 1999 |
| Letter on fda.gov | web.archive.org |
At a glance
- 1–9 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: