Form 483

Columbus Center for Reproductive Endocrinology & Infertility, LLC Form 483, 2025-07-02

FDA issued a Form 483 to Columbus Center for Reproductive Endocrinology & Infertility, LLC on 2025-07-02 with 1 public-safe observation.

483· Form 483 issuedBiologics1 observation

Columbus Center for Reproductive Endocrinology & Infertility, LLC · Columbus, United States · Issued July 2, 2025

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

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

2 Jul 2025
21 CFR 1271.55(c)

Name and personal info on accompanying records

Cited by Christopher J Adams

Inspected site

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1271.55(c)Cited across public-safe Form 483 observations1x

Source document

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Form 483 source document

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Full 483 report

Get the verbatim text of all 1 observation

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