Form 483

Humberto Hernandez, M.D. Form 483, 2022-10-13

FDA issued a Form 483 to Humberto Hernandez, M.D. on 2022-10-13 with 1 public-safe observation.

483· Form 483 issuedHuman Drugs1 observation

Humberto Hernandez, M.D. · Sunrise, United States · Issued October 13, 2022

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

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

13 Oct 2022
21 CFR 312.60

FD-1572, protocol compliance

Cited by Emily A Green, Emily A Baldwin

Inspected site

HHHumberto Hernandez, M.D.Sunrise, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 312.60Cited 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