Form 483

The Maros Group, LLC Form 483, 2025-05-28

FDA issued a Form 483 to The Maros Group, LLC on 2025-05-28 with 8 public-safe observations.

483· Form 483 issuedFoods & Cosmetics8 observations

The Maros Group, LLC · Phoenix, United States · Issued May 28, 2025

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.

28 May 2025
21 CFR 108.25(c)(2)

Process filing

Cited by Megan K Rand

28 May 2025
21 CFR 108.25(g)

Record retention

Cited by Megan K Rand

28 May 2025
21 CFR 114.100(a)

Raw materials, packaging, finished product

Cited by Megan K Rand

28 May 2025
21 CFR 114.80(a)

Quality control procedures

Cited by Megan K Rand

28 May 2025
21 CFR 114.83

Scheduled process establishment

Cited by Megan K Rand

Inspected site

TMThe Maros Group, LLCPhoenix, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 108.25(c)(2)Cited across public-safe Form 483 observations1x
21 CFR 108.25(g)Cited across public-safe Form 483 observations1x
21 CFR 114.100(a)Cited across public-safe Form 483 observations1x
21 CFR 114.80(a)Cited across public-safe Form 483 observations1x
21 CFR 114.83Cited across public-safe Form 483 observations1x
21 CFR 117.10Cited across public-safe Form 483 observations1x
21 CFR 117.35(c)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 8 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

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