Warning letter
Mibo Medical Group: warning letter of Nov 20, 2018
FDA warning letter 558900 · San Francisco District Office
Key facts
| Reference number | 558900 |
|---|---|
| Company | Mibo Medical Group |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Nov 20, 2018 |
| Posted date | Dec 4, 2018 |
| Issuing office | San Francisco District Office |
| Product type | Devices |
| CFR sections cited | 803.17, 820 |
| Inspection city | Dallas |
| Inspection ZIP | 75220 |
| Inspection start date | May 7, 2018 |
| 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: