Form 483

Nutra Solutions USA, Inc. Form 483, 2018-10-18

FDA issued a Form 483 to Nutra Solutions USA, Inc. on 2018-10-18 with 5 public-safe observations.

483· Form 483 issuedFoods & Cosmetics5 observations

Nutra Solutions USA, Inc. · Deer Park, United States · Issued October 18, 2018

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.

18 Oct 2018
21 CFR 111.105(a)

Processes, specifications, written procedures

Cited by Meredith P Soehl

18 Oct 2018
21 CFR 111.110(c)

Quality control operations - tests, examinations; results

Cited by Meredith P Soehl

18 Oct 2018
21 CFR 111.123(a)(7)

Quality control operations - finished batch, specifications

Cited by Meredith P Soehl

18 Oct 2018
21 CFR 111.75(a)(1)(i)

Component - verify identity, dietary ingredient

Cited by Meredith P Soehl

18 Oct 2018
21 CFR 111.75(c)

Specifications met - verify; finished batch

Cited by Meredith P Soehl

Inspected site

NSNutra Solutions USA, Inc.Deer Park, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.105(a)Cited across public-safe Form 483 observations1x
21 CFR 111.110(c)Cited across public-safe Form 483 observations1x
21 CFR 111.123(a)(7)Cited across public-safe Form 483 observations1x
21 CFR 111.75(a)(1)(i)Cited across public-safe Form 483 observations1x
21 CFR 111.75(c)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