Atlas

Form 483

Paul W. Wallace, MD Form 483, 2018-06-08

FDA issued a Form 483 to Paul W. Wallace, MD on 2018-06-08 with 3 public-safe observations.

483· Form 483 issuedHuman Drugs3 observations

Paul W. Wallace, MD · Los Angeles, United States · Issued June 8, 2018

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

8 Jun 2018
21 CFR 312.60

FD-1572, protocol compliance

Cited by Theressa B Smith

8 Jun 2018
21 CFR 312.62(b)

Case history records- inadequate or inadequate

Cited by Theressa B Smith

8 Jun 2018
21 CFR 312.62(c)

Record retention

Cited by Theressa B Smith

Inspected site

PWPaul W. Wallace, MDLos Angeles, United States

Inspection team

TBTheressa B Smith

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(b)Cited across public-safe Form 483 observations1x
21 CFR 312.62(c)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 observations

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