Form 483

RDAG Inc. DBA Gussie's Tamales & Bakery Form 483, 2017-09-19

FDA issued a Form 483 to RDAG Inc. DBA Gussie's Tamales & Bakery on 2017-09-19 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

RDAG Inc. DBA Gussie's Tamales & Bakery · El Paso, United States · Issued September 19, 2017

Overview

  • 4 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.

19 Sep 2017
21 CFR 110.10(b)(6)

Failure to wear

Cited by Ernest Serna

19 Sep 2017
21 CFR 110.35(a)

Buildings/good repair

Cited by Ernest Serna

19 Sep 2017
21 CFR 110.35(a)

Buildings/sanitary

Cited by Ernest Serna

19 Sep 2017
21 CFR 110.80(a)(1)

Storage

Cited by Ernest Serna

Inspected site

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.35(a)Cited across public-safe Form 483 observations2x
21 CFR 110.10(b)(6)Cited across public-safe Form 483 observations1x
21 CFR 110.80(a)(1)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 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