Form 483

Utah Lions Eye Bank Form 483, 2024-04-23

FDA issued a Form 483 to Utah Lions Eye Bank on 2024-04-23 with 2 public-safe observations.

483· Form 483 issuedBiologics2 observations

Utah Lions Eye Bank · Salt Lake City, United States · Issued April 23, 2024

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

23 Apr 2024
21 CFR 1271.160(b)(6)

Deviations--evaluation, cause, corrective action

Cited by Emily B Camire, Dylan R Jock

23 Apr 2024
21 CFR 1271.270(a)

Records incomplete

Cited by Emily B Camire, Dylan R Jock

Inspected site

ULUtah Lions Eye BankSalt Lake City, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1271.160(b)(6)Cited across public-safe Form 483 observations1x
21 CFR 1271.270(a)Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

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