Form 483

Sweets & Desserts, Inc. Form 483, 2016-12-13

FDA issued a Form 483 to Sweets & Desserts, Inc. on 2016-12-13 with 12 public-safe observations.

483· Form 483 issuedFoods & Cosmetics12 observations

Sweets & Desserts, Inc. · Aguas Buenas, United States · Issued December 13, 2016

Overview

  • 12 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.

13 Dec 2016
21 CFR 110.10(c)

Training of handlers and supervisors

Cited by Jorge L Lajara, Marian E Ramirez

13 Dec 2016
21 CFR 110.10(c)

Training of handlers and supervisors

Cited by Jorge L Lajara, Marian E Ramirez

13 Dec 2016
21 CFR 110.35(a)

Cleaning and sanitizing operations

Cited by Jorge L Lajara, Marian E Ramirez

13 Dec 2016
21 CFR 110.35(a)

Cleaning and sanitizing operations

Cited by Jorge L Lajara, Marian E Ramirez

13 Dec 2016
21 CFR 110.35(c)

Lack of effective pest exclusion

Cited by Jorge L Lajara, Marian E Ramirez

Inspected site

S&Sweets & Desserts, Inc.Aguas Buenas, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.10(c)Cited across public-safe Form 483 observations2x
21 CFR 110.35(a)Cited across public-safe Form 483 observations2x
21 CFR 110.35(c)Cited across public-safe Form 483 observations2x
21 CFR 110.80Cited across public-safe Form 483 observations2x
21 CFR 110.80(a)(1)Cited across public-safe Form 483 observations2x
21 CFR 110.93Cited across public-safe Form 483 observations2x

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