Form 483

NutraBio Labs, Inc. Form 483, 2011-08-10

FDA issued a Form 483 to NutraBio Labs, Inc. on 2011-08-10 with 3 public-safe observations.

483· Form 483 issued3 observations

NutraBio Labs, Inc. · Middlesex, United States · Issued August 10, 2011

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

10 Aug 2011
21 CFR 111.12(b)

Personnel - quality control operations

Cited by Russell J Glapion

10 Aug 2011
21 CFR 111.110(a)

QC-Laboratory control processes; production, process control

Cited by Russell J Glapion

10 Aug 2011
21 CFR 111.560(c)

Product complaint - review, investigation

Cited by Russell J Glapion

Inspected site

NLNutraBio Labs, Inc.Middlesex, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.110(a)Cited across public-safe Form 483 observations1x
21 CFR 111.12(b)Cited across public-safe Form 483 observations1x
21 CFR 111.560(c)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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