Form 483

Donald M Brandon MD Form 483, 2023-02-24

FDA issued a Form 483 to Donald M Brandon MD on 2023-02-24 with 1 public-safe observation.

483· Form 483 issuedBiologics1 observation

Donald M Brandon MD · San Diego, United States · Issued February 24, 2023

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.

24 Feb 2023
21 CFR 312.62(b)

Case history records- inadequate or inadequate

Cited by Denise L Burosh

Inspected site

DMDonald M Brandon MDSan Diego, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 312.62(b)Cited across public-safe Form 483 observations1x

Source document

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Form 483 source document

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Full 483 report

Get the verbatim text of all 1 observation

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