Form 483

Scandic Food inc Form 483, 2020-06-09

FDA issued a Form 483 to Scandic Food inc on 2020-06-09 with 5 public-safe observations.

483· Form 483 issuedFoods & Cosmetics5 observations

Scandic Food inc · Kingwood, United States · Issued June 9, 2020

Overview

  • 5 public-safe observations are available for this inspection.
  • 5 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.

9 Jun 2020
21 CFR 1.505(b)

Supplier approval - document

Cited by Brenda C Hamilton

9 Jun 2020
21 CFR 1.506(a)(1)

Approved supplier procedures - importer established

Cited by Brenda C Hamilton

9 Jun 2020
21 CFR 1.506(d)(2)

Onsite audit

Cited by Brenda C Hamilton

9 Jun 2020
21 CFR 1.506(e)(1)(ii)

Sampling, testing

Cited by Brenda C Hamilton

9 Jun 2020
21 CFR 1.506(e)(1)(iii)

Food safety records

Cited by Brenda C Hamilton

Inspected site

SFScandic Food incKingwood, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1.505(b)Cited across public-safe Form 483 observations1x
21 CFR 1.506(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 1.506(d)(2)Cited across public-safe Form 483 observations1x
21 CFR 1.506(e)(1)(ii)Cited across public-safe Form 483 observations1x
21 CFR 1.506(e)(1)(iii)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 5 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