Atlas

Form 483

MAREA DEL SUR GROUP SPA Form 483, 2024-04-15

FDA issued a Form 483 to MAREA DEL SUR GROUP SPA on 2024-04-15 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

MAREA DEL SUR GROUP SPA · Valparaiso, Chile · Issued April 15, 2024

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

15 Apr 2024
21 CFR 123.11(b)

Sanitation monitoring

Cited by Nympha V Florendo

15 Apr 2024
21 CFR 123.6(c)(2)

Critical control points

Cited by Nympha V Florendo

Inspected site

MDMAREA DEL SUR GROUP SPAValparaiso, Chile

Inspection team

NVNympha V Florendo

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 123.11(b)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(2)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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