Warning letter
Tenderneeds Fertility LLC: warning letter of Apr 13, 2020
FDA warning letter 603383 · Division of Medical Device and Radiological Health Operations East
Key facts
| Reference number | 603383 |
|---|---|
| Company | Tenderneeds Fertility LLC |
| Subject | Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) |
| Issue date | Apr 13, 2020 |
| Posted date | Apr 21, 2020 |
| Issuing office | Division of Medical Device and Radiological Health Operations East |
| Product type | Devices |
| CFR sections cited | 801.109(a)(2), 801, 801.109, 803, 803.17, 801.109(b)(1), 801.109(c), 820, 807.81(b), 884.6110, 1271, 1271.21 and 2 more |
| Inspection city | Greenville |
| Inspection ZIP | 47124 |
| Inspection start date | Dec 9, 2019 |
| Letter on fda.gov | fda.gov |
At a glance
- 10–99 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: