Warning letter
Align Technology Inc [ARCHIVED]: warning letter of Nov 17, 2010
FDA warning letter 134650 · San Francisco District Office
Key facts
| Reference number | 134650 |
|---|---|
| Company | Align Technology Inc [ARCHIVED] |
| Subject | Device/Misbranded |
| Issue date | Nov 17, 2010 |
| Posted date | Nov 17, 2010 |
| Issuing office | San Francisco District Office |
| Product type | Devices |
| CFR sections cited | 803.50(a)(1), 803, 803.50(a)(2) |
| Inspection city | San Jose |
| Inspection ZIP | 95134 |
| Inspection start date | Jun 29, 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: