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Form 483

IVF-PGT LAB LLC Form 483, 2019-02-13

FDA issued a Form 483 to IVF-PGT LAB LLC on 2019-02-13 with 3 public-safe observations.

483· Form 483 issuedBiologics3 observations

IVF-PGT LAB LLC · Chicago, United States · Issued February 13, 2019

Overview

  • 3 public-safe observations are 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.

13 Feb 2019
21 CFR 1271.90(c)

Eligibility not required--warning labels

Cited by Uruaku A Obasi

13 Feb 2019
21 CFR 1271.90(c)

Eligibility not required--warning labels

Cited by Uruaku A Obasi

13 Feb 2019
21 CFR 1271.90(c)

Eligibility not required--warning labels

Cited by Uruaku A Obasi

Inspected site

ILIVF-PGT LAB LLCChicago, United States

Inspection team

UAUruaku A Obasi

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1271.90(c)Cited across public-safe Form 483 observations3x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

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Full 483 report

Get the verbatim text of all 3 observations

The source PDF and every observation in full, 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