Form 483

La Sabrosita Company Inc. Form 483, 2015-07-24

FDA issued a Form 483 to La Sabrosita Company Inc. on 2015-07-24 with 12 public-safe observations.

483· Form 483 issuedFoods & Cosmetics12 observations

La Sabrosita Company Inc. · North Chesterfield, United States · Issued July 24, 2015

Overview

  • 12 public-safe observations are available for this inspection.
  • 12 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.

24 Jul 2015
21 CFR 110.10(b)(3)

Not washed/sanitized when appropriate

Cited by Tiki Dixon

24 Jul 2015
21 CFR 110.10(b)(4)

Unsecured jewelry

Cited by Tiki Dixon

24 Jul 2015
21 CFR 110.20(b)(6)

Fans/air blowing equipment

Cited by Tiki Dixon

24 Jul 2015
21 CFR 110.35(a)

Buildings/sanitary

Cited by Tiki Dixon

24 Jul 2015
21 CFR 110.37(d)(4)

Doors opening into processing areas

Cited by Tiki Dixon

Inspected site

LSLa Sabrosita Company Inc.North Chesterfield, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.10(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 110.10(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(6)Cited across public-safe Form 483 observations1x
21 CFR 110.35(a)Cited across public-safe Form 483 observations1x
21 CFR 110.37(d)(4)Cited across public-safe Form 483 observations1x
21 CFR 110.40(a)Cited across public-safe Form 483 observations1x
21 CFR 110.80(a)(7)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(13)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(6)Cited across public-safe Form 483 observations1x
21 CFR 110.93Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 12 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