Warning letter
Biostructures, LLC [ARCHIVED]: warning letter of Oct 7, 2010
FDA warning letter 113928 · Los Angeles District Office
Key facts
| Reference number | 113928 |
|---|---|
| Company | Biostructures, LLC [ARCHIVED] |
| Subject | Premarket Approval/Adulterated/Misbranded |
| Issue date | Oct 7, 2010 |
| Posted date | Oct 7, 2010 |
| Issuing office | Los Angeles District Office |
| Product type | Devices |
| CFR sections cited | 807.81(a)(3)(ii), 807.81(b) |
| Inspection city | Newport Beach |
| Inspection ZIP | 92660 |
| Inspection start date | May 12, 2010 |
| Letter on fda.gov | web.archive.org |
At a glance
- 1–9 CFR sections cited
- VAI 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: