Form 483

Tan Nam Corporation Form 483, 2017-07-20

FDA issued a Form 483 to Tan Nam Corporation on 2017-07-20 with 6 public-safe observations.

483· Form 483 issuedFoods & Cosmetics6 observations

Tan Nam Corporation · Rosemead, United States · Issued July 20, 2017

Overview

  • 6 public-safe observations are available for this inspection.
  • 6 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.

20 Jul 2017
21 CFR 110.10(b)(6)

Effective use of hair restraint

Cited by Grace P Santos

20 Jul 2017
21 CFR 110.35(a)

Buildings/sanitary

Cited by Grace P Santos

20 Jul 2017
21 CFR 110.35(d)

Failure to clean - general

Cited by Grace P Santos

20 Jul 2017
21 CFR 110.35(d)(5)

Shown to be effective

Cited by Grace P Santos

20 Jul 2017
21 CFR 110.80(b)(1)

Maintenance of equip., utensils, and finished food packaging

Cited by Grace P Santos

Inspected site

TNTan Nam CorporationRosemead, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.10(b)(6)Cited across public-safe Form 483 observations1x
21 CFR 110.35(a)Cited across public-safe Form 483 observations1x
21 CFR 110.35(d)Cited across public-safe Form 483 observations1x
21 CFR 110.35(d)(5)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(7)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 6 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