Warning letter
AireRx Healthcare, LLC: warning letter of Jul 27, 2012
FDA warning letter 313279 · New Orleans District Office
Key facts
| Reference number | 313279 |
|---|---|
| Company | AireRx Healthcare, LLC |
| Subject | CGMP for Medical Devices/QSR/Adulterated/Misbranded |
| Issue date | Jul 27, 2012 |
| Posted date | Jul 27, 2012 |
| Issuing office | New Orleans District Office |
| Product type | Devices |
| CFR sections cited | 803.17, 807.81, 820, 890.3920 |
| Inspection city | Hendersonville |
| Inspection ZIP | 37075 |
| Inspection start date | Apr 9, 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: