Form 483

Modern Macaroni Co Ltd Form 483, 2016-02-04

FDA issued a Form 483 to Modern Macaroni Co Ltd on 2016-02-04 with 10 public-safe observations.

483· Form 483 issuedFoods & Cosmetics10 observations

Modern Macaroni Co Ltd · Waipahu, United States · Issued February 4, 2016

Overview

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

Inspectional observations

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

4 Feb 2016
21 CFR 110.10(b)(3)

Not washed/sanitized when appropriate

Cited by Lynn L Wong, Stuart Kim, John Cook

4 Feb 2016
21 CFR 110.10(b)(8)

Personal food/drink/tobacco

Cited by Lynn L Wong, Stuart Kim, John Cook

4 Feb 2016
21 CFR 110.20(a)(1)

Harborage areas

Cited by Lynn L Wong, Stuart Kim, John Cook

4 Feb 2016
21 CFR 110.80(b)(5)

Work-in-progress

Cited by Lynn L Wong, Stuart Kim, John Cook

4 Feb 2016
21 CFR 123.11(b)

Sanitation monitoring

Cited by Lynn L Wong, Stuart Kim, John Cook

Inspected site

MMModern Macaroni Co LtdWaipahu, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.10(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 110.10(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 110.10(b)(8)Cited across public-safe Form 483 observations1x
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 123.11(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 10 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