Overview
- 8 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-05-24.
At a glance
Inspections
8
Form 483s
7
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 22 May 2024 – 24 May 2024 | Biologics | Clean | |
| 16 Jun 2022 – 29 Jun 2022 | Biologics | 483 | View 483 → |
| 14 Jan 2020 – 12 Feb 2020 | Biologics | 483 | View 483 → |
| 4 Dec 2017 – 21 Dec 2017 | Biologics | 483 | View 483 → |
| 24 Aug 2016 – 15 Sep 2016 | Biologics | 483 | View 483 → |
| 8 Sep 2014 – 18 Sep 2014 | Biologics | 483 | View 483 → |
| 26 Jul 2013 – 31 Jul 2013 | Biologics | WL | View 483 → |
| 14 Jan 2010 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
29 Jun 2022
21 CFR 1271.47(a)
Testing, screening, donor eligibility procedures
Cited by Amy Kim, Amy W Yan Mai, Amy W Yan-Mai
29 Jun 2022
21 CFR 1271.75(a)(1)
Risk factors, clinical evidence
Cited by Amy Kim, Amy W Yan Mai, Amy W Yan-Mai
12 Feb 2020
21 CFR 1271.47(a)
Testing, screening, donor eligibility procedures
Cited by Irina Gaberman, Monika Borkowska
12 Feb 2020
21 CFR 1271.47(a)
Testing, screening, donor eligibility procedures
Cited by Irina Gaberman, Monika Borkowska
12 Feb 2020
21 CFR 1271.75(a)(1)
Risk factors, clinical evidence
Cited by Irina Gaberman, Monika Borkowska
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 1271.55(d)(2) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 1271.75(a)(1) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 1271.47(a) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 1271.50(a) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 1271.50(b)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.80(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.85(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.75(a)(2) | 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 |
Full site report
Get the verbatim findings behind Manhattan Reproductive Medicine, PC's 7 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