Form 483

Tortilleria Cadengo Form 483, 2016-08-31

FDA issued a Form 483 to Tortilleria Cadengo on 2016-08-31 with 15 public-safe observations.

483· Form 483 issuedFoods & Cosmetics15 observations

Tortilleria Cadengo · Southaven, United States · Issued August 31, 2016

Overview

  • 15 public-safe observations are available for this inspection.
  • 15 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.

31 Aug 2016
21 CFR 110.10(b)(1)

Suitable outer garments

Cited by Charvais S Hill, Charvais S Bogan

31 Aug 2016
21 CFR 110.10(b)(3)

Not washed/sanitized when appropriate

Cited by Charvais S Hill, Charvais S Bogan

31 Aug 2016
21 CFR 110.10(b)(6)

Failure to wear

Cited by Charvais S Hill, Charvais S Bogan

31 Aug 2016
21 CFR 110.10(b)(7)

Storage of personal items

Cited by Charvais S Hill, Charvais S Bogan

31 Aug 2016
21 CFR 110.10(b)(8)

Personal food/drink/tobacco

Cited by Charvais S Hill, Charvais S Bogan

Inspected site

TCTortilleria CadengoSouthaven, United States

Inspection team

CSCharvais S Bogan

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.10(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.10(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 110.10(b)(6)Cited across public-safe Form 483 observations1x
21 CFR 110.10(b)(7)Cited across public-safe Form 483 observations1x
21 CFR 110.10(b)(8)Cited across public-safe Form 483 observations1x
21 CFR 110.20(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(5)Cited across public-safe Form 483 observations1x
21 CFR 110.35(a)Cited across public-safe Form 483 observations1x
21 CFR 110.35(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.35(c)Cited across public-safe Form 483 observations1x
21 CFR 110.35(d)Cited across public-safe Form 483 observations1x
21 CFR 110.37(e)Cited across public-safe Form 483 observations1x
21 CFR 110.37(e)(5)Cited across public-safe Form 483 observations1x
21 CFR 110.40(b)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(7)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 15 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