Atlas

Form 483

NutraBio Labs, Inc. Form 483, 2016-01-29

FDA issued a Form 483 to NutraBio Labs, Inc. on 2016-01-29 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

NutraBio Labs, Inc. · Middlesex, United States · Issued January 29, 2016

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.

29 Jan 2016
21 CFR 111.14(b)(2)

Personnel - records - training

Cited by Doreen P Gubbay

29 Jan 2016
21 CFR 111.303

Written procedures - laboratory operations

Cited by Doreen P Gubbay

29 Jan 2016
FDCA 761(b)(1)

No AE report made (dietary supplement)

Cited by Doreen P Gubbay

Inspected site

NLNutraBio Labs, Inc.Middlesex, United States

Inspection team

DPDoreen P Gubbay

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.14(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 111.303Cited across public-safe Form 483 observations1x
FDCA 761(b)(1)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