Atlas

Form 483

Novel Laboratories, Inc. d.b.a Lupin Somerset Form 483, 2018-02-23

FDA issued a Form 483 to Novel Laboratories, Inc. d.b.a Lupin Somerset on 2018-02-23 with 4 public-safe observations.

483· Form 483 issuedHuman Drugs4 observations

Novel Laboratories, Inc. d.b.a Lupin Somerset · Somerset, United States · Issued February 23, 2018

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

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

23 Feb 2018
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Sena G Dissmeyer, Nancy M Espinal

23 Feb 2018
21 CFR 211.42(c)

Defined areas of adequate size for operations

Cited by Sena G Dissmeyer, Nancy M Espinal

23 Feb 2018
21 CFR 211.137(a)

Expiration date lacking

Cited by Sena G Dissmeyer, Nancy M Espinal

23 Feb 2018
21 CFR 211.63

Equipment Design, Size and Location

Cited by Sena G Dissmeyer, Nancy M Espinal

Inspected site

NLNovel Laboratories, Inc. d.b.a Lupin SomersetSomerset, United States

Inspection team

SGSena G Dissmeyer
NMNancy M Espinal

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.137(a)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)Cited across public-safe Form 483 observations1x
21 CFR 211.63Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 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