Warning letter
CellEra LLC: warning letter of Oct 20, 2021
FDA warning letter 618209 · Office of Medical Device and Radiological Health Division 1 – East
Key facts
| Reference number | 618209 |
|---|---|
| Company | CellEra LLC |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Oct 20, 2021 |
| Posted date | Nov 2, 2021 |
| Issuing office | Office of Medical Device and Radiological Health Division 1 – East |
| Product type | Devices |
| CFR sections cited | 803, 803.17, 820, 820.40 |
| Inspection city | Monroe |
| Inspection ZIP | 45050 |
| Inspection start date | Jun 16, 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: