Form 483

American Sugar Refining, Inc. Form 483, 2024-09-11

FDA issued a Form 483 to American Sugar Refining, Inc. on 2024-09-11 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

American Sugar Refining, Inc. · Baltimore, United States · Issued September 11, 2024

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.

11 Sep 2024
21 CFR 117.135(a)(1)

Process preventive controls - Implement

Cited by Mohamad A Chahine

11 Sep 2024
21 CFR 117.35(e)

Sanitation of non-food-contact surfaces - Manner and frequency

Cited by Mohamad A Chahine

11 Sep 2024
21 CFR 117.80(c)

Manufacturing, processing, packing, holding - Controls

Cited by Mohamad A Chahine

Inspected site

ASAmerican Sugar Refining, Inc.Baltimore, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.135(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 117.35(e)Cited across public-safe Form 483 observations1x
21 CFR 117.80(c)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 observations

The full inspection record, as Atlas holds it, 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