Form 483

Yamaya USA Inc Form 483, 2011-04-13

FDA issued a Form 483 to Yamaya USA Inc on 2011-04-13 with 4 public-safe observations.

483· Form 483 issued4 observations

Yamaya USA Inc · Torrance, United States · Issued April 13, 2011

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 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.

13 Apr 2011
21 CFR 123.6(b)

HACCP plan implementation

Cited by Henry E Carrillo

13 Apr 2011
21 CFR 123.6(c)(2)

Critical control points

Cited by Henry E Carrillo

13 Apr 2011
21 CFR 123.6(c)(3)

Critical limits

Cited by Henry E Carrillo

13 Apr 2011
21 CFR 123.12(a)(2)

Importer verification

Cited by Henry E Carrillo

Inspected site

YUYamaya USA IncTorrance, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 123.12(a)(2)Cited across public-safe Form 483 observations1x
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 4 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