Atlas

Form 483

Agricola Los Medanos S.A. Form 483, 2016-03-01

FDA issued a Form 483 to Agricola Los Medanos S.A. on 2016-03-01 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

Agricola Los Medanos S.A. · Ica, Peru · Issued March 1, 2016

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.

1 Mar 2016
21 CFR 110.20(b)(4)

Drip and condensate

Cited by Young M Yoon

1 Mar 2016
21 CFR 110.80(b)(5)

Work-in-progress

Cited by Young M Yoon

Inspected site

ALAgricola Los Medanos S.A.Ica, Peru

Inspection team

YMYoung M Yoon

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.20(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(5)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 observations

Every observation in full, 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