Form 483

TBN FOOD PRODUCTS Form 483, 2017-04-18

FDA issued a Form 483 to TBN FOOD PRODUCTS on 2017-04-18 with 8 public-safe observations.

483· Form 483 issuedFoods & Cosmetics8 observations

TBN FOOD PRODUCTS · Sto Tomas, Philippines · Issued April 18, 2017

Overview

  • 8 public-safe observations are available for this inspection.
  • 8 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.

18 Apr 2017
21 CFR 113.40(i)

Critical factor - scheduled process

Cited by Nympha V Florendo

18 Apr 2017
21 CFR 113.40(j)

Other systems: Methods, controls - scheduled process

Cited by Nympha V Florendo

18 Apr 2017
21 CFR 113.60(b)

Cooling water - not chlorinated, sanitized

Cited by Nympha V Florendo

18 Apr 2017
21 CFR 113.87(c)

Initial temperature of container contents

Cited by Nympha V Florendo

18 Apr 2017
21 CFR 114.100(e)

Retention

Cited by Nympha V Florendo

Inspected site

TFTBN FOOD PRODUCTSSto Tomas, Philippines

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 113.40(i)Cited across public-safe Form 483 observations1x
21 CFR 113.40(j)Cited across public-safe Form 483 observations1x
21 CFR 113.60(b)Cited across public-safe Form 483 observations1x
21 CFR 113.87(c)Cited across public-safe Form 483 observations1x
21 CFR 114.100(e)Cited across public-safe Form 483 observations1x
21 CFR 114.80(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 114.80(a)(4)Cited across public-safe Form 483 observations1x
21 CFR 114.89Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 8 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