Form 483

SAKSCO Gourmet Basket Supplies Inc. Form 483, 2020-06-15

FDA issued a Form 483 to SAKSCO Gourmet Basket Supplies Inc. on 2020-06-15 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

SAKSCO Gourmet Basket Supplies Inc. · Sanborn, United States · Issued June 15, 2020

Overview

  • 3 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.

15 Jun 2020
21 CFR 1.504(a)

Hazard analysis written

Cited by Shannon A Dinardo

15 Jun 2020
21 CFR 1.505(b)

Supplier approval - document

Cited by Shannon A Dinardo

15 Jun 2020
21 CFR 1.506(b)

Supplier verification - establish written procedures

Cited by Shannon A Dinardo

Inspected site

SGSAKSCO Gourmet Basket Supplies Inc.Sanborn, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1.504(a)Cited across public-safe Form 483 observations1x
21 CFR 1.505(b)Cited across public-safe Form 483 observations1x
21 CFR 1.506(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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