Atlas

Form 483

Tolmar, Inc. Form 483, 2016-04-15

FDA issued a Form 483 to Tolmar, Inc. on 2016-04-15 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Tolmar, Inc. · Windsor, United States · Issued April 15, 2016

Overview

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

Inspectional observations

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

15 Apr 2016
21 CFR 211.100(b)

SOPs not followed / documented

Cited by Zachary L Stamm, Zachery L Miller, Jamie L Dion

15 Apr 2016
21 CFR 211.194(a)(5)

Calculations performed are in the records

Cited by Zachary L Stamm, Zachery L Miller, Jamie L Dion

Inspected site

TITolmar, Inc.Windsor, United States

Inspection team

ZLZachary L Stamm
ZLZachery L Miller
JLJamie L Dion

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.100(b)Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)(5)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 observations

The full inspection record, as Atlas holds it, 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