Warning letter
Sunstar Americas, Inc.: warning letter of Dec 21, 2021
FDA warning letter 614058 · Office of Medical Devices and Radiological Health Operations Div. 2 Central
Key facts
| Reference number | 614058 |
|---|---|
| Company | Sunstar Americas, Inc. |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Dec 21, 2021 |
| Posted date | Jan 18, 2022 |
| Issuing office | Office of Medical Devices and Radiological Health Operations Div. 2 Central |
| Product type | Drugs |
| CFR sections cited | 211.34, 211.192, 211.22(a), 211.100(a), 211.160(b), 820 |
| Inspection city | Schaumburg |
| Inspection ZIP | 60195 |
| Inspection start date | Jan 12, 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: