Form 483

Whitmore Family Enterprises, LLC Form 483, 2014-10-13

FDA issued a Form 483 to Whitmore Family Enterprises, LLC on 2014-10-13 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

Whitmore Family Enterprises, LLC · Somerville, United States · Issued October 13, 2014

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 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.

13 Oct 2014
21 CFR 110.20(b)(4)

Spacing of equipment

Cited by Arie Menachem

13 Oct 2014
21 CFR 110.80

Reasonable precautions

Cited by Arie Menachem

13 Oct 2014
21 CFR 110.80(b)(2)

Manufacturing conditions

Cited by Arie Menachem

13 Oct 2014
21 CFR 110.80(b)(6)

Contamination by raw materials, refuse, other ingredients

Cited by Arie Menachem

Inspected site

WFWhitmore Family Enterprises, LLCSomerville, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.20(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 110.80Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(6)Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

Full 483 report

Get the verbatim text of all 4 observations

The source PDF and 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