Warning letter
King Systems Corp. dba Ambu, Inc.: warning letter of Aug 16, 2023
FDA warning letter 661617 · "OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices, Office of Product Evaluation and Quality"
Key facts
| Reference number | 661617 |
|---|---|
| Company | King Systems Corp. dba Ambu, Inc. |
| Subject | CGMP/QSR/Medical Devices/PMA/Adulterated/Misbranded |
| Issue date | Aug 16, 2023 |
| Posted date | Aug 22, 2023 |
| Issuing office | "OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices, Office of Product Evaluation and Quality" |
| Product type | Devices |
| CFR sections cited | 807.81(b) |
| Inspection city | Noblesville |
| Inspection ZIP | 46060 |
| Inspection start date | May 15, 2023 |
| 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: