Warning letter
Flawless Beauty and Skin: warning letter of Aug 5, 2022
FDA warning letter 630567 · Center for Devices and Radiological Health
Key facts
| Reference number | 630567 |
|---|---|
| Company | Flawless Beauty and Skin |
| Subject | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device |
| Issue date | Aug 5, 2022 |
| Posted date | Oct 4, 2022 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 807.3(g), 807.81(b), 807.20(a)(5) |
| Inspection city | Ocean |
| Inspection ZIP | 07712-3948 |
| Inspection start date | Nov 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: