Form 483

ANI Pharmaceuticals Canada, Inc. Form 483, 2016-12-09

FDA issued a Form 483 to ANI Pharmaceuticals Canada, Inc. on 2016-12-09 with 3 public-safe observations.

483· Form 483 issuedHuman Drugs3 observations

ANI Pharmaceuticals Canada, Inc. · Oakville, Canada · Issued December 9, 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.

9 Dec 2016

21 CFR 211.100(a)

Absence of Written Procedures

Cited by Ivy E Sweeney

9 Dec 2016

21 CFR 211.166(a)

Written program not followed

Cited by Ivy E Sweeney

9 Dec 2016

21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Ivy E Sweeney

Inspected site

APANI Pharmaceuticals Canada, Inc.Oakville, Canada

Inspection team

IEIvy E Sweeney

Cited regulations

CFR citations associated with this Form 483.

Citation	What it covers	Cited
21 CFR 211.100(a)	Cited across public-safe Form 483 observations	1x
21 CFR 211.166(a)	Cited across public-safe Form 483 observations	1x
21 CFR 211.22(d)	Cited across public-safe Form 483 observations	1x

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