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Form 483

John M Wo MD Form 483, 2021-07-23

FDA issued a Form 483 to John M Wo MD on 2021-07-23 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

John M Wo MD · Indianapolis, United States · Issued July 23, 2021

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 structured CFR citations are represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

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

23 Jul 2021
21 CFR 312.62(b)

Case history records- inadequate or inadequate

Cited by Andrace Deyampert

23 Jul 2021
21 CFR 312.66

Initial and continuing review

Cited by Andrace Deyampert

Inspected site

JMJohn M Wo MDIndianapolis, United States

Inspection team

ADAndrace Deyampert

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 312.62(b)Cited across public-safe Form 483 observations1x
21 CFR 312.66Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

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Full 483 report

Get the verbatim text of all 2 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