Form 483

Cti Biopharma Inc Form 483, 2016-06-15

FDA issued a Form 483 to Cti Biopharma Inc on 2016-06-15 with 1 public-safe observation.

483· Form 483 issuedHuman Drugs1 observation

Cti Biopharma Inc · Seattle, United States · Issued June 15, 2016

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 3 investigators are tied to this Form 483.

Inspectional observations

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

15 Jun 2016
21 CFR 312.56(c)

IND safety report

Cited by Sunitha K Rajaram, Phillip D Kronstein, Romeo A De Claro

Inspected site

CBCti Biopharma IncSeattle, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 312.56(c)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 1 observation

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