Atlas

Form 483

Drouyn & Co., Inc. Form 483, 2019-09-20

FDA issued a Form 483 to Drouyn & Co., Inc. on 2019-09-20 with 6 public-safe observations.

483· Form 483 issuedFoods & Cosmetics6 observations

Drouyn & Co., Inc. · Guaynabo, United States · Issued September 20, 2019

Overview

  • 6 public-safe observations are available for this inspection.
  • 3 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.

20 Sep 2019
21 CFR 117.126(a)(1)

Food Safety Plan

Cited by Miguel G Manzano

20 Sep 2019
21 CFR 117.130(a)(2)

Hazard Analysis - Written

Cited by Miguel G Manzano

20 Sep 2019
21 CFR 117.35(a)

Sanitary Operations - Plant Sanitation

Cited by Miguel G Manzano

20 Sep 2019
21 CFR 117.126(a)(1)

Food Safety Plan

Cited by Miguel G Manzano

20 Sep 2019
21 CFR 117.130(a)(2)

Hazard Analysis - Written

Cited by Miguel G Manzano

Inspected site

D&Drouyn & Co., Inc.Guaynabo, United States

Inspection team

MGMiguel G Manzano

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.126(a)(1)Cited across public-safe Form 483 observations2x
21 CFR 117.130(a)(2)Cited across public-safe Form 483 observations2x
21 CFR 117.35(a)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 6 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