Overview
- 2 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2021-09-29.
At a glance
Inspections
2
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 25 Aug 2021 – 29 Sep 2021 | Biologics | 483 | View 483 → |
| 9 Dec 2019 – 13 Dec 2019 | Biologics | WL | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
29 Sep 2021
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Talmane J Fisher, Leeterry Moore
29 Sep 2021
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Talmane J Fisher, Leeterry Moore
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 803.17 | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.30(a) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.30(j) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 1271.47(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 1271.50(a) | Cited across public-safe Form 483 observations | 3x |
Full site report
Get the verbatim findings behind Tenderneeds Fertility LLC's 2 Form 483s
Source PDFs and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat