Form 483

Omya Inc. Form 483, 2016-07-25

FDA issued a Form 483 to Omya Inc. on 2016-07-25 with 3 public-safe observations.

483· Form 483 issuedHuman Drugs3 observations

Omya Inc. · Superior, United States · Issued July 25, 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.

25 Jul 2016

21 CFR 211.160(b)(4)

Calibration - at intervals, written program, remedial action

Cited by William J Leonard

25 Jul 2016

21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by William J Leonard

25 Jul 2016

21 CFR 211.25(a)

Training--operations, GMPs, written procedures

Cited by William J Leonard

Inspected site

OIOmya Inc.Superior, United States

Inspection team

WJWilliam J Leonard

Cited regulations

CFR citations associated with this Form 483.

Citation	What it covers	Cited
21 CFR 211.160(b)(4)	Cited across public-safe Form 483 observations	1x
21 CFR 211.22(d)	Cited across public-safe Form 483 observations	1x
21 CFR 211.25(a)	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