Warning letter
Medtronic Puerto Rico Operations Co.: warning letter of Aug 23, 2018
FDA warning letter 562437 · Florida District Office
Key facts
| Reference number | 562437 |
|---|---|
| Company | Medtronic Puerto Rico Operations Co. |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Aug 23, 2018 |
| Posted date | Sep 11, 2018 |
| Issuing office | Florida District Office |
| Product type | Devices |
| CFR sections cited | 820 |
| Inspection city | Juncos |
| Inspection ZIP | 00777 |
| Inspection start date | Apr 23, 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: