Atlas

Form 483

Focus Surgical Inc Form 483, 2014-10-10

FDA issued a Form 483 to Focus Surgical Inc on 2014-10-10 with 1 public-safe observation.

483· Form 483 issuedBiologics1 observation

Focus Surgical Inc · Brisbane, United States · Issued October 10, 2014

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.

10 Oct 2014
21 CFR 1271.160(a)

All core requirements covered in program

Cited by Roger D Gawne

Inspected site

FSFocus Surgical IncBrisbane, United States

Inspection team

RDRoger D Gawne

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1271.160(a)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