Overview
- 3 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2025-04-02.
At a glance
Inspections
3
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 28 Mar 2025 – 2 Apr 2025 | Biologics | 483 | View 483 → |
| 24 Sep 2020 – 25 Sep 2020 | Biologics | Clean | |
| 12 May 2017 – 16 May 2017 | Biologics | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
2 Apr 2025
21 CFR 1271.55(b)(2)
Listing and interpretation of CD tests performed
Cited by Emily S Mcgann
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 1271.47(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.47(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.50(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.55(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.55(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.55(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.75(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.80(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind New Directions Fertility Center's 1 Form 483
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