Warning letter
Circulatory Technology, Inc.: warning letter of Jan 28, 2019
FDA warning letter 572970 · New England District Office
Key facts
| Reference number | 572970 |
|---|---|
| Company | Circulatory Technology, Inc. |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Jan 28, 2019 |
| Posted date | Feb 12, 2019 |
| Issuing office | New England District Office |
| Product type | Devices |
| CFR sections cited | 820 |
| Inspection city | Oyster Bay |
| Inspection ZIP | 11771 |
| Inspection start date | Aug 22, 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: