Warning letter
Panbio, Inc.: warning letter of Oct 5, 2005
FDA warning letter UCM075596 · Baltimore District Office
Key facts
| Reference number | UCM075596 |
|---|---|
| Company | Panbio, Inc. |
| Subject | Lacks Premarket Approval Application/Misbranded |
| Issue date | Oct 5, 2005 |
| Posted date | Oct 5, 2005 |
| Issuing office | Baltimore District Office |
| Product type | Biologics |
| CFR sections cited | 864.4020(a), 820.3, 807.81(b) |
| Country | 3 |
| Inspection city | Columbia |
| Inspection ZIP | 21046-3145 |
| Inspection start date | May 4, 2005 |
| 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: