Form 483

LABORATORIO DE DIAGNOSTICOS Y ALIMENTACION 2008 SLU Form 483, 2026-01-28

FDA issued a Form 483 to LABORATORIO DE DIAGNOSTICOS Y ALIMENTACION 2008 SLU on 2026-01-28 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

LABORATORIO DE DIAGNOSTICOS Y ALIMENTACION 2008 SLU · Boecillo, Spain · Issued January 28, 2026

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.

28 Jan 2026
21 CFR 211.68(a)

Calibration/Inspection/Checking not done

Cited by Bijoy Panicker

28 Jan 2026
21 CFR 211.68(b)

Computer control of master formula records

Cited by Bijoy Panicker

Inspected site

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.68(a)Cited across public-safe Form 483 observations1x
21 CFR 211.68(b)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