Atlas

Form 483

San Clemente Foods S.A. Form 483, 2014-05-13

FDA issued a Form 483 to San Clemente Foods S.A. on 2014-05-13 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

San Clemente Foods S.A. · Talca, Chile · Issued May 13, 2014

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.

13 May 2014
21 CFR 120.8(b)(4)

HACCP plan - monitoring procedures - none listed

Cited by Joseph T Frost

13 May 2014
21 CFR 120.11(a)(1)(iv)

Verification - CCP, CA record review

Cited by Joseph T Frost

13 May 2014
21 CFR 120.11(b)

HACCP plan - not validated

Cited by Joseph T Frost

Inspected site

SCSan Clemente Foods S.A.Talca, Chile

Inspection team

JTJoseph T Frost

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 120.11(a)(1)(iv)Cited across public-safe Form 483 observations1x
21 CFR 120.11(b)Cited across public-safe Form 483 observations1x
21 CFR 120.8(b)(4)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