Atlas

Form 483

Grand Strand Sandwich Company,Inc. Form 483, 2018-12-13

FDA issued a Form 483 to Grand Strand Sandwich Company,Inc. on 2018-12-13 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

Grand Strand Sandwich Company,Inc. · Longs, United States · Issued December 13, 2018

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 structured CFR citations are represented.
  • 5 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

13 Dec 2018
21 CFR 117.130(a)(1)

Hazard Analysis - Identification of Hazard

Cited by Shayla G Turnipseed, N'Jere English, Myckie M Jacobsen, Tamayo C Barnes, Nelson A Rodriguez

13 Dec 2018
21 CFR 117.145(a)

Allergen Controls Monitoring Proced: Establish Implement

Cited by Shayla G Turnipseed, N'Jere English, Myckie M Jacobsen, Tamayo C Barnes, Nelson A Rodriguez

Inspected site

GSGrand Strand Sandwich Company,Inc.Longs, United States

Inspection team

SGShayla G Turnipseed
NEN'Jere English
MMMyckie M Jacobsen
TCTamayo C Barnes
NANelson A Rodriguez

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.130(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 117.145(a)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