Form 483

Nana Barseghian, M.D. Form 483, 2024-02-16

FDA issued a Form 483 to Nana Barseghian, M.D. on 2024-02-16 with 3 public-safe observations.

483· Form 483 issuedHuman Drugs3 observations

Nana Barseghian, M.D. · Northridge, United States · Issued February 16, 2024

Overview

  • 3 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.

16 Feb 2024
21 CFR 312.60

FD-1572, protocol compliance

Cited by Cheron M Portee, Jasmine Y Wang

16 Feb 2024
21 CFR 312.60

Informed consent

Cited by Cheron M Portee, Jasmine Y Wang

16 Feb 2024
21 CFR 312.62(b)

Case history records- inadequate or inadequate

Cited by Cheron M Portee, Jasmine Y Wang

Inspected site

NBNana Barseghian, M.D.Northridge, 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 observations2x
21 CFR 312.62(b)Cited across public-safe Form 483 observations1x

Source document

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PDF available

Form 483 source document

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Full 483 report

Get the verbatim text of all 3 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