Form 483

Summit Nutritionals International Inc. Form 483, 2015-11-10

FDA issued a Form 483 to Summit Nutritionals International Inc. on 2015-11-10 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

Summit Nutritionals International Inc. · Branchburg, United States · Issued November 10, 2015

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

10 Nov 2015
21 CFR 110.35(d)

Failure to clean - general

Cited by Melissa A Freeman, Doreen P Gubbay

10 Nov 2015
21 CFR 110.80(a)(1)

Storage

Cited by Melissa A Freeman, Doreen P Gubbay

Inspected site

SNSummit Nutritionals International Inc.Branchburg, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.35(d)Cited across public-safe Form 483 observations1x
21 CFR 110.80(a)(1)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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