Form 483

Modern Macaroni Co Ltd Form 483, 2016-12-13

FDA issued a Form 483 to Modern Macaroni Co Ltd on 2016-12-13 with 8 public-safe observations.

483· Form 483 issuedFoods & Cosmetics8 observations

Modern Macaroni Co Ltd · Waipahu, United States · Issued December 13, 2016

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.

13 Dec 2016
21 CFR 110.20(a)(1)

Harborage areas

Cited by Lynn L Wong

13 Dec 2016
21 CFR 110.35(c)

Lack of effective pest exclusion

Cited by Lynn L Wong

13 Dec 2016
21 CFR 110.40(a)

Food-contact - withstand food & cleaning cmpds.

Cited by Lynn L Wong

13 Dec 2016
21 CFR 110.80(b)(5)

Work-in-progress

Cited by Lynn L Wong

13 Dec 2016
21 CFR 123.10

HACCP training or qualification

Cited by Lynn L Wong

Inspected site

MMModern Macaroni Co LtdWaipahu, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.20(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.35(c)Cited across public-safe Form 483 observations1x
21 CFR 110.40(a)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(5)Cited across public-safe Form 483 observations1x
21 CFR 123.10Cited across public-safe Form 483 observations1x
21 CFR 123.11(b)Cited across public-safe Form 483 observations1x
21 CFR 123.11(c)Cited across public-safe Form 483 observations1x
21 CFR 123.6(b)Cited 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