Warning letter
CardioQuip, LLC: warning letter of Feb 11, 2022
FDA warning letter 621738 · Center for Devices and Radiological Health
Key facts
| Reference number | 621738 |
|---|---|
| Company | CardioQuip, LLC |
| Subject | CGMP/QSR/Medical Devices/PMA/Adulterated |
| Issue date | Feb 11, 2022 |
| Posted date | Mar 8, 2022 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 803, 803.3, 803.50(a)(2), 807.81(a)(3), 820, 807.81(b) |
| Inspection city | College Station |
| Inspection ZIP | 77845 |
| Inspection start date | Aug 19, 2021 |
| 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: