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Form 483

UCLA Medical IRB 1 (OHRPP) Form 483, 2019-06-26

FDA issued a Form 483 to UCLA Medical IRB 1 (OHRPP) on 2019-06-26 with 1 public-safe observation.

483· Form 483 issuedHuman Drugs1 observation

UCLA Medical IRB 1 (OHRPP) · Los Angeles, United States · Issued June 26, 2019

Overview

  • 1 public-safe observation is 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.

26 Jun 2019
21 CFR 56.107(c)

One scientific and one non-scientific member

Cited by Humberto Z Gomez

Inspected site

UMUCLA Medical IRB 1 (OHRPP)Los Angeles, United States

Inspection team

HZHumberto Z Gomez

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 56.107(c)Cited across public-safe Form 483 observations1x

Source document

PDF
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Form 483 source document

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Full 483 report

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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