Form 483

Southwest Fertility Center Form 483, 2026-04-14

FDA issued a Form 483 to Southwest Fertility Center on 2026-04-14 with 5 public-safe observations.

483· Form 483 issuedBiologics5 observations

Southwest Fertility Center · Phoenix, United States · Issued April 14, 2026

Overview

  • 5 public-safe observations are available for this inspection.
  • 5 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.

14 Apr 2026
21 CFR 1271.50(b)(2)

Donor testing not negative for CD agents

Cited by Garrad R Poole

14 Apr 2026
21 CFR 1271.55(b)(2)

Listing and interpretation of CD tests performed

Cited by Garrad R Poole

14 Apr 2026
21 CFR 1271.55(d)(1)(iii)

Documentation--determination, by whom, date

Cited by Garrad R Poole

14 Apr 2026
21 CFR 1271.55(d)(2)

Accurate, indelible, legible

Cited by Garrad R Poole

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

Risk factors, clinical evidence

Cited by Garrad R Poole

Inspected site

SFSouthwest Fertility CenterPhoenix, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1271.50(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 1271.55(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 1271.55(d)(1)(iii)Cited across public-safe Form 483 observations1x
21 CFR 1271.55(d)(2)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 5 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