Form 483

Michigan Reproductive and IVF Center, PLLC Form 483, 2026-06-03

FDA issued a Form 483 to Michigan Reproductive and IVF Center, PLLC on 2026-06-03 with 5 public-safe observations.

483· Form 483 issuedBiologics5 observations

Michigan Reproductive and IVF Center, PLLC · Grand Rapids, United States · Issued June 3, 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.

3 Jun 2026
21 CFR 1271.47(a)

Testing, screening, donor eligibility procedures

Cited by Irina Gaberman

3 Jun 2026
21 CFR 1271.50(a)

Determination based on screening and testing

Cited by Irina Gaberman

3 Jun 2026
21 CFR 1271.55(d)(2)

Accurate, indelible, legible

Cited by Irina Gaberman

3 Jun 2026
21 CFR 1271.75(a)(1)

Risk factors, clinical evidence

Cited by Irina Gaberman

3 Jun 2026
21 CFR 1271.75(b)

Risk factors, leukocyte-rich cells or tissues

Cited by Irina Gaberman

Inspected site

MRMichigan Reproductive and IVF Center, PLLCGrand Rapids, 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 1271.55(d)(2)Cited across public-safe Form 483 observations1x
21 CFR 1271.75(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 1271.75(b)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