Form 483

New Infertility Center of St Louis Form 483, 2026-04-22

FDA issued a Form 483 to New Infertility Center of St Louis on 2026-04-22 with 3 public-safe observations.

483· Form 483 issuedBiologics3 observations

New Infertility Center of St Louis · Chesterfield, United States · Issued April 22, 2026

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

22 Apr 2026
21 CFR 1271.47(a)

Design of procedures to ensure compliance

Cited by Lesley Mae P Lutao

22 Apr 2026
21 CFR 1271.50(a)

Determination based on screening and testing

Cited by Lesley Mae P Lutao

22 Apr 2026
21 CFR 1271.75(a)(1)

Risk factors, clinical evidence

Cited by Lesley Mae P Lutao

Inspected site

NINew Infertility Center of St LouisChesterfield, United States

Inspection team

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 1271.50(a)Cited across public-safe Form 483 observations1x
21 CFR 1271.75(a)(1)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 observations

The full inspection record, as Atlas holds it, 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