Form 483

Larso LLC Form 483, 2014-07-17

FDA issued a Form 483 to Larso LLC on 2014-07-17 with 7 public-safe observations.

483· Form 483 issuedFoods & Cosmetics7 observations

Larso LLC · Johnston, United States · Issued July 17, 2014

Overview

  • 7 public-safe observations are available for this inspection.
  • 6 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

17 Jul 2014
21 CFR 120.6(b)

Sanitation monitoring

Cited by Mancia R Walker, Mary F Bodick

17 Jul 2014
21 CFR 120.8(a)

HACCP plan - location and type of juice

Cited by Mancia R Walker, Mary F Bodick

17 Jul 2014
21 CFR 120.8(a)

HACCP plan not implemented

Cited by Mancia R Walker, Mary F Bodick

17 Jul 2014
21 CFR 120.10(c)

Corrective action documentation

Cited by Mancia R Walker, Mary F Bodick

17 Jul 2014
21 CFR 120.11(a)(1)

Verification activities - minimum

Cited by Mancia R Walker, Mary F Bodick

Inspected site

LLLarso LLCJohnston, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 120.8(a)Cited across public-safe Form 483 observations2x
21 CFR 120.10(c)Cited across public-safe Form 483 observations1x
21 CFR 120.11(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 120.11(a)(1)(iv)Cited across public-safe Form 483 observations1x
21 CFR 120.12(c)Cited across public-safe Form 483 observations1x
21 CFR 120.6(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 7 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