Warning letter
Human Biosciences, Inc.: warning letter of May 10, 2012
FDA warning letter 281637 · Baltimore District Office
Key facts
| Reference number | 281637 |
|---|---|
| Company | Human Biosciences, Inc. |
| Subject | Premarket Approval/Misbranded |
| Issue date | May 10, 2012 |
| Posted date | May 10, 2012 |
| Issuing office | Baltimore District Office |
| Product type | Devices |
| CFR sections cited | 807.81(a)(3)(ii), 807.81, 807.81(a)(3)(i), 807.81(b) |
| Inspection city | Gaithersburg |
| Inspection ZIP | 20878 |
| Inspection start date | Sep 7, 2011 |
| 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: