Atlas

Form 483

Trilliant Surgical Ltd. Form 483, 2011-09-09

FDA issued a Form 483 to Trilliant Surgical Ltd. on 2011-09-09 with 3 public-safe observations.

483· Form 483 issued3 observations

Trilliant Surgical Ltd. · Houston, United States · Issued September 9, 2011

Overview

  • 3 public-safe observations are available for this inspection.
  • 2 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.

9 Sep 2011
21 CFR 820.22

Quality Audit/Reaudit - conducted

Cited by Andrea A Branche

9 Sep 2011
21 CFR 820.22

Quality audits - auditor independence

Cited by Andrea A Branche

9 Sep 2011
21 CFR 820.100(b)

Documentation

Cited by Andrea A Branche

Inspected site

TSTrilliant Surgical Ltd.Houston, United States

Inspection team

AAAndrea A Branche

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.22Cited across public-safe Form 483 observations2x
21 CFR 820.100(b)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