Overview
- 8 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-02-22.
At a glance
Inspections
8
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 8 Feb 2023 – 22 Feb 2023 | Biologics | 483 | View 483 → |
| 16 Feb 2022 – 23 Feb 2022 | Biologics | 483 | View 483 → |
| 21 Jun 2018 – 6 Jul 2018 | Biologics | Clean | |
| 26 May 2016 – 6 Jul 2016 | Biologics | 483 | View 483 → |
| 25 Nov 2013 – 6 Dec 2013 | Biologics | Clean | |
| 24 May 2012 | Not recorded | 483 | View 483 → |
| 18 Aug 2010 | Not recorded | Clean | |
| 11 Aug 2009 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
23 Feb 2022
21 CFR 1271.47(a)
Testing, screening, donor eligibility procedures
Cited by Kathleen B Swat, Emily A Walters
23 Feb 2022
21 CFR 1271.55(b)(2)
Listing and interpretation of CD tests performed
Cited by Kathleen B Swat, Emily A Walters
23 Feb 2022
21 CFR 1271.60(c)
Shipped but not kept in quarantine
Cited by Kathleen B Swat, Emily A Walters
23 Feb 2022
21 CFR 1271.75(a)(1)
Risk factors, clinical evidence
Cited by Kathleen B Swat, Emily A Walters
Investigators
FDA investigators tied to this site in the record.
Emily A Walters2 insp.
Jennifer L Custodio2 insp.
Christina N Maurino2 insp.
Lisa Mathew2 insp.
Kathleen B Swat1 insp.
Denise M Visco1 insp.
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 | 6x |
| 21 CFR 1271.75(a)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 1271.50(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.80(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.47(b) | 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 1271.55(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.60(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.65(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.75(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.75(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.80(d)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.85(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.85(b)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Diamond Institute for Infertility and Menopause's 5 Form 483s
Source PDFs, verbatim observations, 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