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Form 483

Madhukar H. Trivedi, MD Form 483, 2019-01-11

FDA issued a Form 483 to Madhukar H. Trivedi, MD on 2019-01-11 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Madhukar H. Trivedi, MD · Dallas, United States · Issued January 11, 2019

Overview

  • 2 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.

11 Jan 2019
21 CFR 312.60

FD-1572, protocol compliance

Cited by Mathew T Thomas, Camille D Brown

11 Jan 2019
21 CFR 312.62(c)

Record retention

Cited by Mathew T Thomas, Camille D Brown

Inspected site

MHMadhukar H. Trivedi, MDDallas, United States

Inspection team

MTMathew T Thomas
CDCamille D Brown

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 312.60Cited across public-safe Form 483 observations1x
21 CFR 312.62(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

Get the verbatim text of all 2 observations

The source PDF and every observation in full, 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