Form 483

Keybio Form 483, 2016-01-13

FDA issued a Form 483 to Keybio on 2016-01-13 with 1 public-safe observation.

483· Form 483 issuedHuman Drugs1 observation

Keybio · Aubagne, France · Issued January 13, 2016

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is 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 Jan 2016
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Sarah M Meng

Inspected site

KKeybioAubagne, France

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 1 observation

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