Warning letter
Horiba Instruments, Inc dba Horiba Medical: warning letter of Jul 25, 2012
FDA warning letter 289898 · Los Angeles District Office
Key facts
| Reference number | 289898 |
|---|---|
| Company | Horiba Instruments, Inc dba Horiba Medical |
| Subject | Premarket Approval/Adulterated/Misbranded |
| Issue date | Jul 25, 2012 |
| Posted date | Jul 25, 2012 |
| Issuing office | Los Angeles District Office |
| Product type | Devices |
| CFR sections cited | 806, 806.20(b)(4), 820, 807.81(b) |
| Inspection city | Irvine |
| Inspection ZIP | 92618 |
| Inspection start date | Feb 15, 2012 |
| 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: