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Form 483

One Solution, LLC dba Complete Packaging & Manufacturing Form 483, 2016-09-08

FDA issued a Form 483 to One Solution, LLC dba Complete Packaging & Manufacturing on 2016-09-08 with 48 public-safe observations.

483· Form 483 issuedFoods & Cosmetics48 observations

One Solution, LLC dba Complete Packaging & Manufacturing · Orem, United States · Issued September 8, 2016

Overview

  • 48 public-safe observations are available for this inspection.
  • 16 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.

8 Sep 2016
21 CFR 111.155(c)

Components - quarantine

Cited by Jennifer A Robinson

8 Sep 2016
21 CFR 111.205(a)

Master manufacturing record - each batch

Cited by Jennifer A Robinson

8 Sep 2016
21 CFR 111.255(b)

Batch record - complete

Cited by Jennifer A Robinson

8 Sep 2016
21 CFR 111.255(b)

Batch record - complete

Cited by Jennifer A Robinson

8 Sep 2016
21 CFR 111.365(i)

Metal, foreign material

Cited by Jennifer A Robinson

Inspected site

OSOne Solution, LLC dba Complete Packaging & ManufacturingOrem, United States

Inspection team

JAJennifer A Robinson

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.155(c)Cited across public-safe Form 483 observations3x
21 CFR 111.205(a)Cited across public-safe Form 483 observations3x
21 CFR 111.255(b)Cited across public-safe Form 483 observations3x
21 CFR 111.365(i)Cited across public-safe Form 483 observations3x
21 CFR 111.410(b)Cited across public-safe Form 483 observations3x
21 CFR 111.410(d)Cited across public-safe Form 483 observations3x
21 CFR 111.535(b)(1)Cited across public-safe Form 483 observations3x
21 CFR 111.553Cited across public-safe Form 483 observations3x
21 CFR 111.65Cited across public-safe Form 483 observations3x
21 CFR 111.70(b)(1)Cited across public-safe Form 483 observations3x
21 CFR 111.70(b)(2)Cited across public-safe Form 483 observations3x
21 CFR 111.70(e)Cited across public-safe Form 483 observations3x
21 CFR 111.75(a)(1)(i)Cited across public-safe Form 483 observations3x
21 CFR 111.75(a)(2)(ii)(A)Cited across public-safe Form 483 observations3x
21 CFR 111.75(b)(1)Cited across public-safe Form 483 observations3x
21 CFR 111.75(c)Cited across public-safe Form 483 observations3x

Full 483 report

Get the verbatim text of all 48 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