Warning letter
BioCheck Inc [ARCHIVED]: warning letter of Dec 7, 2010
FDA warning letter 130510 · San Francisco District Office
Key facts
| Reference number | 130510 |
|---|---|
| Company | BioCheck Inc [ARCHIVED] |
| Subject | Premarket Approval/Adulterated/Misbranded |
| Issue date | Dec 7, 2010 |
| Posted date | Dec 7, 2010 |
| Issuing office | San Francisco District Office |
| Product type | Devices |
| CFR sections cited | 801.4, 807.81(b) |
| Inspection city | South San Francisco |
| Inspection ZIP | 94080 |
| Inspection start date | Jun 9, 2010 |
| 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: