Atlas

Form 483

Niagara Pharmaceuticals, Inc Form 483, 2016-05-16

FDA issued a Form 483 to Niagara Pharmaceuticals, Inc on 2016-05-16 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Niagara Pharmaceuticals, Inc · Dundas, Canada · Issued May 16, 2016

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.

16 May 2016
21 CFR 211.165(a)

Testing and release for distribution

Cited by Arsen Karapetyan

16 May 2016
21 CFR 211.80(d)

Identification of Each Lot in Each Shipment

Cited by Arsen Karapetyan

Inspected site

NPNiagara Pharmaceuticals, IncDundas, Canada

Inspection team

AKArsen Karapetyan

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.165(a)Cited across public-safe Form 483 observations1x
21 CFR 211.80(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