Warning letter
Elkhart General Hospital Blood Donor Center [ARCHIVED]: warning letter of May 6, 2009
FDA warning letter 50159 · Detroit District Office
Key facts
| Reference number | 50159 |
|---|---|
| Company | Elkhart General Hospital Blood Donor Center [ARCHIVED] |
| Subject | CGMP Regulations for Blood and Blood Components |
| Issue date | May 6, 2009 |
| Posted date | May 6, 2009 |
| Issuing office | Detroit District Office |
| Product type | Biologics |
| CFR sections cited | 610.41(a), 610.40(a), 610.40(h)(1), 610.41, 610.46, 610.47, 610.48, 610.41(b), 606.100(b), 606.160(e) |
| Inspection city | Elkhart |
| Inspection ZIP | 46514 |
| Inspection start date | Dec 1, 2008 |
| Letter on fda.gov | web.archive.org |
At a glance
- 10–99 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: