Form 483

Lusamerica Foods Inc Form 483, 2014-04-03

FDA issued a Form 483 to Lusamerica Foods Inc on 2014-04-03 with 6 public-safe observations.

483· Form 483 issuedFoods & Cosmetics6 observations

Lusamerica Foods Inc · Morgan Hill, United States · Issued April 3, 2014

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.

3 Apr 2014
21 CFR 110.20(b)(2)

Contamination with microorganisms, chemicals, filth, etc.

Cited by Cathryn M Groehnert

3 Apr 2014
21 CFR 110.20(b)(4)

Floors, walls and ceilings

Cited by Cathryn M Groehnert

3 Apr 2014
21 CFR 123.6(c)(3)

Critical limits

Cited by Cathryn M Groehnert

3 Apr 2014
21 CFR 123.6(c)(4)

Monitoring - adequacy

Cited by Cathryn M Groehnert

3 Apr 2014
21 CFR 123.6(c)(6)

Verification procedures - adequacy

Cited by Cathryn M Groehnert

Inspected site

LFLusamerica Foods IncMorgan Hill, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.20(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 123.12(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(3)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(4)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(6)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