Warning letter
Hand Biomechanics Lab Inc: warning letter of Nov 16, 2017
FDA warning letter 534495 · Los Angeles District Office
Key facts
| Reference number | 534495 |
|---|---|
| Company | Hand Biomechanics Lab Inc |
| Subject | Medical Device Reporting/Misbranded |
| Issue date | Nov 16, 2017 |
| Posted date | Dec 5, 2017 |
| Issuing office | Los Angeles District Office |
| Product type | Devices |
| CFR sections cited | 803.50(a), 803, 803.3, 803.17, 803.50(a)(1), 820 |
| Inspection city | Sacramento |
| Inspection ZIP | 95825 |
| Inspection start date | Jun 22, 2017 |
| Letter on fda.gov | fda.gov |
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: