Atlas

Form 483

NOVA LABORATORIES LIMITED Form 483, 2016-03-03

FDA issued a Form 483 to NOVA LABORATORIES LIMITED on 2016-03-03 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

NOVA LABORATORIES LIMITED · Wigston, United Kingdom · Issued March 3, 2016

Overview

  • 2 public-safe observations are available for this inspection.
  • 1 structured CFR citation is represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

3 Mar 2016
21 CFR 211.103

Actual vs. theoretical yields not determined

Cited by Francis A Guidry

3 Mar 2016
21 CFR 211.103

Actual vs. theoretical yields not determined

Cited by Francis A Guidry

Inspected site

NLNOVA LABORATORIES LIMITEDWigston, United Kingdom

Inspection team

FAFrancis A Guidry

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.103Cited across public-safe Form 483 observations2x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

Book a demoStart a free trial

Full 483 report

Get the verbatim text of all 2 observations

The source PDF and 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