Atlas

Form 483

CorneaGen - Orlando / Medical Eye Bank of Florida Form 483, 2015-04-01

FDA issued a Form 483 to CorneaGen - Orlando / Medical Eye Bank of Florida on 2015-04-01 with 3 public-safe observations.

483· Form 483 issuedBiologics3 observations

CorneaGen - Orlando / Medical Eye Bank of Florida · Orlando, United States · Issued April 1, 2015

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

1 Apr 2015
21 CFR 1271.180(b)

Review and approval-responsible person

Cited by Stacey F Rivette

1 Apr 2015
21 CFR 1271.230(a)

Documented, dated, signed

Cited by Stacey F Rivette

1 Apr 2015
21 CFR 1271.350(a)(2)

15 day reporting timeframe

Cited by Stacey F Rivette

Inspected site

C-CorneaGen - Orlando / Medical Eye Bank of FloridaOrlando, United States

Inspection team

SFStacey F Rivette

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1271.180(b)Cited across public-safe Form 483 observations1x
21 CFR 1271.230(a)Cited across public-safe Form 483 observations1x
21 CFR 1271.350(a)(2)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 observations

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