Atlas

Form 483

Shirakawa Olympus Co., Ltd. Form 483, 2012-03-15

FDA issued a Form 483 to Shirakawa Olympus Co., Ltd. on 2012-03-15 with 1 public-safe observation.

483· Form 483 issued1 observation

Shirakawa Olympus Co., Ltd. · Nishishirakawa-Gun, Japan · Issued March 15, 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.

15 Mar 2012
21 CFR 820.30(g)

Design validation- Lack of or inadequate procedures

Cited by Frank J Marciniak

Inspected site

SOShirakawa Olympus Co., Ltd.Nishishirakawa-Gun, Japan

Inspection team

FJFrank J Marciniak

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.30(g)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