Warning letter
Tesla BioHealing, Inc.: warning letter of Aug 10, 2023
FDA warning letter 658010 · Division of Medical Device and Radiological Health Operations East
Key facts
| Reference number | 658010 |
|---|---|
| Company | Tesla BioHealing, Inc. |
| Subject | Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) |
| Issue date | Aug 10, 2023 |
| Posted date | Aug 29, 2023 |
| Issuing office | Division of Medical Device and Radiological Health Operations East |
| Product type | Devices |
| CFR sections cited | 820, 890.9(a), 890.5500, 890.9, 807.81(b) |
| Inspection city | Milford |
| Inspection ZIP | 19963 |
| Inspection start date | Mar 20, 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: