Atlas

Form 483

Newton Laboratories, Inc. Form 483, 2017-03-29

FDA issued a Form 483 to Newton Laboratories, Inc. on 2017-03-29 with 2 public-safe observations.

483· Form 483 issuedAnimal Drugs & Feeds2 observations

Newton Laboratories, Inc. · Conyers, United States · Issued March 29, 2017

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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 Mar 2017
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Tamara J Henderson

29 Mar 2017
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Tamara J Henderson

Inspected site

NLNewton Laboratories, Inc.Conyers, United States

Inspection team

TJTamara J Henderson

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)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