Form 483

El Gordo Spices, LLC Form 483, 2012-04-20

FDA issued a Form 483 to El Gordo Spices, LLC on 2012-04-20 with 6 public-safe observations.

483· Form 483 issued6 observations

El Gordo Spices, LLC · Dallas, United States · Issued April 20, 2012

Overview

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

Inspectional observations

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

20 Apr 2012
21 CFR 110.20(b)(1)

Sufficient space

Cited by Yaw O Osei, Paul E Frazier

20 Apr 2012
21 CFR 110.20(b)(2)

Contamination with microorganisms, chemicals, filth, etc.

Cited by Yaw O Osei, Paul E Frazier

20 Apr 2012
21 CFR 110.20(b)(6)

Fans/air blowing equipment

Cited by Yaw O Osei, Paul E Frazier

20 Apr 2012
21 CFR 110.35(c)

Lack of effective pest exclusion

Cited by Yaw O Osei, Paul E Frazier

20 Apr 2012
21 CFR 110.80

Reasonable precautions

Cited by Yaw O Osei, Paul E Frazier

Inspected site

EGEl Gordo Spices, LLCDallas, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.20(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(6)Cited across public-safe Form 483 observations1x
21 CFR 110.35(c)Cited across public-safe Form 483 observations1x
21 CFR 110.80Cited across public-safe Form 483 observations1x
21 CFR 123.6(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 6 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