Atlas

Form 483

CorneaGen LLC Form 483, 2021-09-24

FDA issued a Form 483 to CorneaGen LLC on 2021-09-24 with 2 public-safe observations.

483· Form 483 issuedBiologics2 observations

CorneaGen LLC · Seattle, United States · Issued September 24, 2021

Overview

  • 2 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.

24 Sep 2021
21 CFR 1271.55(b)(3)

Name and address on summary

Cited by Peter S Kessler

24 Sep 2021
21 CFR 1271.55(b)(3)

Name and address on summary

Cited by Peter S Kessler

Inspected site

CLCorneaGen LLCSeattle, United States

Inspection team

PSPeter S Kessler

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1271.55(b)(3)Cited across public-safe Form 483 observations2x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

Book a demoStart a free trial

Full 483 report

Get the verbatim text of all 2 observations

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