Form 483

IVF Laboratories of Grand Rapids LLC Form 483, 2023-04-27

FDA issued a Form 483 to IVF Laboratories of Grand Rapids LLC on 2023-04-27 with 1 public-safe observation.

483· Form 483 issuedBiologics1 observation

IVF Laboratories of Grand Rapids LLC · Grand Rapids, United States · Issued April 27, 2023

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.

27 Apr 2023
21 CFR 1271.60(b)

Identified as quarantined, distinguishable

Cited by Erma Zaimova

Inspected site

ILIVF Laboratories of Grand Rapids LLCGrand Rapids, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1271.60(b)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