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Form 483

Baton Rouge General Medical Center IRB Form 483, 2023-09-14

FDA issued a Form 483 to Baton Rouge General Medical Center IRB on 2023-09-14 with 3 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health3 observations

Baton Rouge General Medical Center IRB · Baton Rouge, United States · Issued September 14, 2023

Overview

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

14 Sep 2023
21 CFR 50.52

Factors required for approval

Cited by Dana M Klimavicz, Christopher M Jeffers

14 Sep 2023
21 CFR 56.108(b)(2)

Prompt reporting of noncompliance

Cited by Dana M Klimavicz, Christopher M Jeffers

14 Sep 2023
21 CFR 56.115(a)(2)

Minutes of IRB meetings

Cited by Dana M Klimavicz, Christopher M Jeffers

Inspected site

BRBaton Rouge General Medical Center IRBBaton Rouge, United States

Inspection team

DMDana M Klimavicz
CMChristopher M Jeffers

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 50.52Cited across public-safe Form 483 observations1x
21 CFR 56.108(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 56.115(a)(2)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 observations

The full inspection record, as Atlas holds it, 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