Warning letter
IsoAid, L.L.C.: warning letter of Aug 16, 2012
FDA warning letter 329180 · Florida District Office
Key facts
| Reference number | 329180 |
|---|---|
| Company | IsoAid, L.L.C. |
| Subject | CGMP/QSR/Adulterated |
| Issue date | Aug 16, 2012 |
| Posted date | Aug 16, 2012 |
| Issuing office | Florida District Office |
| Product type | Devices |
| CFR sections cited | 803, 803.17, 803.17(a)(1), 803.17(a)(2), 803.17(a)(3), 803.17(b)(1), 820 |
| Inspection city | Port Richey |
| Inspection ZIP | 34668 |
| Inspection start date | Apr 12, 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: