Warning letter
Alphatec Spine, Inc. [ARCHIVED]: warning letter of Jun 21, 2010
FDA warning letter 100065 · Los Angeles District Office
Key facts
| Reference number | 100065 |
|---|---|
| Company | Alphatec Spine, Inc. [ARCHIVED] |
| Subject | CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated/Misbranded |
| Issue date | Jun 21, 2010 |
| Posted date | Jun 21, 2010 |
| Issuing office | Los Angeles District Office |
| Product type | Devices |
| CFR sections cited | 803.56, 803, 803.50(a)(2), 820, 803.50(b)(3) |
| Inspection city | Carlsbad |
| Inspection ZIP | 92008 |
| Inspection start date | Jan 20, 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: