FDA-Inspected Site

Manhattan Fertility Services LLC

5 FDA inspections are on record for Manhattan Fertility Services LLC in New York, United States.

483· Form 483 issued

New York, United States · Last updated July 10, 2026

Overview

  • 5 FDA inspections are on record.
  • 4 inspections produced a Form 483.
  • The most recent recorded inspection date is 2024-11-05.

At a glance

Inspections

5

Form 483s

4

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
25 Oct 2024 – 5 Nov 2024Biologics483View 483 →
15 Mar 2023 – 6 Apr 2023Biologics483View 483 →
29 Oct 2019 – 27 Nov 2019BiologicsClean
6 Jun 2018 – 10 Jul 2018Biologics483View 483 →
1 Apr 2016 – 11 Apr 2016Biologics483View 483 →

Observations on record

Form 483 observations cited at this site, most recent first.

5 Nov 2024
21 CFR 1271.47(a)

Testing, screening, donor eligibility procedures

Cited by Irina Gaberman

5 Nov 2024
21 CFR 1271.50(a)

Determination based on screening and testing

Cited by Irina Gaberman

5 Nov 2024
21 CFR 1271.55(d)(2)

Accurate, indelible, legible

Cited by Irina Gaberman

5 Nov 2024
21 CFR 1271.65(b)(2)

Prominently labeled (limited use)

Cited by Irina Gaberman

6 Apr 2023
21 CFR 1271.65(b)(2)

Labeled re: biohazard, risks, test results

Cited by Amy Kim

Investigators

FDA investigators tied to this site in the record.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 1271.47(a)Cited across public-safe Form 483 observations6x
21 CFR 1271.75(a)(1)Cited across public-safe Form 483 observations3x
21 CFR 1271.55(b)(4)Cited across public-safe Form 483 observations2x
21 CFR 1271.65(b)(2)Cited across public-safe Form 483 observations2x
21 CFR 1271.50(a)Cited across public-safe Form 483 observations1x
21 CFR 1271.55(a)(3)Cited across public-safe Form 483 observations1x
21 CFR 1271.55(d)(2)Cited across public-safe Form 483 observations1x
21 CFR 1271.80(b)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Manhattan Fertility Services LLC's 4 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