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Form 483

Sher Fertility Solutions New York Form 483, 2022-04-01

FDA issued a Form 483 to Sher Fertility Solutions New York on 2022-04-01 with 2 public-safe observations.

483· Form 483 issuedBiologics2 observations

Sher Fertility Solutions New York · New York, United States · Issued April 1, 2022

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 structured CFR citations are represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

1 Apr 2022
21 CFR 1271.47(a)

Testing, screening, donor eligibility procedures

Cited by Irina Gaberman

1 Apr 2022
21 CFR 1271.80(b)

Specimen collections not timely

Cited by Irina Gaberman

Inspected site

SFSher Fertility Solutions New YorkNew York, United States

Inspection team

IGIrina Gaberman

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1271.47(a)Cited across public-safe Form 483 observations1x
21 CFR 1271.80(b)Cited across public-safe Form 483 observations1x

Source document

PDF
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Form 483 source document

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Full 483 report

Get the verbatim text of all 2 observations

The source PDF, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere