FDA-Inspected Site

Batzofin Fertility Services

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

483· Form 483 issued

New York, United States · Last updated July 9, 2026

Overview

  • 5 FDA inspections are on record.
  • 3 inspections produced a Form 483.
  • The most recent recorded inspection date is 2019-04-29.

At a glance

Inspections

5

Form 483s

3

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
15 Apr 2019 – 29 Apr 2019Biologics483View 483 →
13 Feb 2017 – 16 Feb 2017BiologicsClean
5 May 2015 – 6 May 2015BiologicsClean
6 May 2013 – 10 May 2013Biologics483View 483 →
5 May 2011Not recorded483View 483 →

Observations on record

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

29 Apr 2019
21 CFR 1271.47(a)

Donor eligibility procedures

Cited by Irina Gaberman

29 Apr 2019
21 CFR 1271.47(a)

Donor eligibility procedures

Cited by Irina Gaberman

29 Apr 2019
21 CFR 1271.50(b)(1)

Donor screening standards

Cited by Irina Gaberman

29 Apr 2019
21 CFR 1271.50(b)(1)

Donor screening standards

Cited by Irina Gaberman

29 Apr 2019
21 CFR 1271.75(a)(1)

Risk factors, clinical evidence

Cited by Irina Gaberman

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 1271.50(a)Cited across public-safe Form 483 observations2x
21 CFR 1271.50(b)(1)Cited across public-safe Form 483 observations2x
21 CFR 1271.75(a)(1)Cited across public-safe Form 483 observations2x
21 CFR 1271.80(b)Cited across public-safe Form 483 observations2x
21 CFR 1271.55(d)(2)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Batzofin Fertility Services' 3 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