Form 483

Toby's Family Foods LLC Form 483, 2016-11-02

FDA issued a Form 483 to Toby's Family Foods LLC on 2016-11-02 with 5 public-safe observations.

483· Form 483 issuedFoods & Cosmetics5 observations

Toby's Family Foods LLC · Springfield, United States · Issued November 2, 2016

Overview

  • 5 public-safe observations are available for this inspection.
  • 5 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.

2 Nov 2016
21 CFR 120.11(a)(2)

Calibration, testing - no records

Cited by Devon M Shoop

2 Nov 2016
21 CFR 120.24(b)

Process controls - direct treatment - not exempt

Cited by Devon M Shoop

2 Nov 2016
21 CFR 120.11(a)(1)(iv)

Records - not signed and dated by qualified individual

Cited by Devon M Shoop

2 Nov 2016
21 CFR 120.11(b)

HACCP plan - not validated

Cited by Devon M Shoop

2 Nov 2016
21 CFR 120.8(a)

No HACCP plan

Cited by Devon M Shoop

Inspected site

TFToby's Family Foods LLCSpringfield, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 120.11(a)(1)(iv)Cited across public-safe Form 483 observations1x
21 CFR 120.11(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 120.11(b)Cited across public-safe Form 483 observations1x
21 CFR 120.24(b)Cited across public-safe Form 483 observations1x
21 CFR 120.8(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 5 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