Form 483

MEDINA USA LLC Form 483, 2023-02-14

FDA issued a Form 483 to MEDINA USA LLC on 2023-02-14 with 1 public-safe observation.

483· Form 483 issuedFoods & Cosmetics1 observation

MEDINA USA LLC · San Juan, United States · Issued February 14, 2023

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

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

14 Feb 2023
21 CFR 1.502(a)

Develop FSVP

Cited by Enrique Galan

Inspected site

MUMEDINA USA LLCSan Juan, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1.502(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 1 observation

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