Atlas

Form 483

Imuraya USA, INC. Form 483, 2012-01-04

FDA issued a Form 483 to Imuraya USA, INC. on 2012-01-04 with 1 public-safe observation.

483· Form 483 issued1 observation

Imuraya USA, INC. · Irvine, United States · Issued January 4, 2012

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.

4 Jan 2012
21 CFR 110.93

Storage/transportation of finished goods (deterioration)

Cited by Rochelle A Rolnik

Inspected site

IUImuraya USA, INC.Irvine, United States

Inspection team

RARochelle A Rolnik

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.93Cited 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