Warning letter
Maquet Cardiovascular, LLC [ARCHIVED]: warning letter of Aug 11, 2010
FDA warning letter 125431 · New Jersey District Office
Key facts
| Reference number | 125431 |
|---|---|
| Company | Maquet Cardiovascular, LLC [ARCHIVED] |
| Subject | CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated |
| Issue date | Aug 11, 2010 |
| Posted date | Aug 11, 2010 |
| Issuing office | New Jersey District Office |
| Product type | Devices |
| CFR sections cited | 806, 820, 806.10(a) |
| Inspection city | Wayne |
| Inspection ZIP | 07470 |
| Inspection start date | Apr 13, 2010 |
| 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: