Warning letter
Eastern Cranial Affiliates, LLC [ARCHIVED]: warning letter of Nov 16, 2010
FDA warning letter 128630 · Baltimore District Office
Key facts
| Reference number | 128630 |
|---|---|
| Company | Eastern Cranial Affiliates, LLC [ARCHIVED] |
| Subject | CGMP/QSR/Medical Device Reporting/Misbranded |
| Issue date | Nov 16, 2010 |
| Posted date | Nov 16, 2010 |
| Issuing office | Baltimore District Office |
| Product type | Devices |
| CFR sections cited | 807.97, 820, 820.40 |
| Inspection city | Fairfax |
| Inspection ZIP | 22030 |
| Inspection start date | Jun 15, 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: