Atlas

Form 483

Seiki, Inc. Form 483, 2009-12-01

FDA issued a Form 483 to Seiki, Inc. on 2009-12-01 with 3 public-safe observations.

483· Form 483 issued3 observations

Seiki, Inc. · Kagoshima, Japan · Issued December 1, 2009

Overview

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

1 Dec 2009
21 CFR 123.6(b)

HACCP plan implementation

Cited by Katherine M Taylor

1 Dec 2009
21 CFR 123.6(c)(2)

Critical control points

Cited by Katherine M Taylor

1 Dec 2009
21 CFR 123.6(c)(3)

Critical limits

Cited by Katherine M Taylor

Inspected site

SISeiki, Inc.Kagoshima, Japan

Inspection team

KMKatherine M Taylor

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 123.6(b)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(2)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(3)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