Atlas

Form 483

Beckman Research Institute, City of Hope Form 483, 2018-12-13

FDA issued a Form 483 to Beckman Research Institute, City of Hope on 2018-12-13 with 3 public-safe observations.

483· Form 483 issuedHuman Drugs3 observations

Beckman Research Institute, City of Hope · Duarte, United States · Issued December 13, 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.

13 Dec 2018
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Carrie A Hughes

13 Dec 2018
21 CFR 211.194(c)

Testing and standardization of standards et. al.

Cited by Carrie A Hughes

13 Dec 2018
21 CFR 211.63

Equipment Design, Size and Location

Cited by Carrie A Hughes

Inspected site

BRBeckman Research Institute, City of HopeDuarte, United States

Inspection team

CACarrie A Hughes

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.194(c)Cited across public-safe Form 483 observations1x
21 CFR 211.63Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 observations

The full inspection record, as Atlas holds it, 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