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Form 483

Trividia Manufacturing Solutions Form 483, 2018-11-07

FDA issued a Form 483 to Trividia Manufacturing Solutions on 2018-11-07 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

Trividia Manufacturing Solutions · Lancaster, United States · Issued November 7, 2018

Overview

  • 2 public-safe observations are 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.

7 Nov 2018
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by James W Whitney

7 Nov 2018
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by James W Whitney

Inspected site

TMTrividia Manufacturing SolutionsLancaster, United States

Inspection team

JWJames W Whitney

Cited regulations

CFR citations associated with this Form 483.

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

Full 483 report

Get the verbatim text of all 2 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