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•United States

Tolmar, Inc., Fort Collins, CO – FDA Inspections

Inspection records and compliance data for Tolmar, Inc. in Fort Collins, Colorado. 11 FDA inspections on record, 3 Form 483s, last inspected February 23, 2024.

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Company Profile

This profile covers Tolmar, Inc. based in Fort Collins, Colorado, United States.

FDA Inspection History

FDA inspections
11
OAI
0
VAI
10
NAI
1
Form 483s
3
Warning letters
0

First inspected December 11, 2009. Last inspected February 23, 2024.

Most cited issue areas

  • Procedures for sterile drug products2 inspections
  • Absence of Written Procedures1 inspection
  • Cleaning / Sanitizing / Maintenance1 inspection

FDA inspections (11)

DateResultFDA center(s)Insp. #
February 23, 2024VAIHuman Drugs · Postmarket Surv. and Epidemiology1230026
January 31, 2023VAIHuman Drugs · Drug Quality Assurance1196737
January 28, 2020VAIHuman Drugs · Drug Quality Assurance1116204
April 6, 2018VAIHuman Drugs · Bioresearch Monitoring1056151
December 6, 2017VAIAnimal Drugs & Feeds, Human Drugs, Medical Devices & Rad Health · Drug Quality Assurance1034036
September 20, 2016NAIAnimal Drugs & Feeds, Human Drugs · Monitoring of Marketed Animal Drugs, Feed, and Devices988191
February 16, 2014VAIAnimal Drugs & Feeds, Human Drugs · Drug Quality Assurance883509
May 31, 2013VAIHuman Drugs · Drug Quality Assurance835870
September 7, 2012VAIAnimal Drugs & Feeds, Human Drugs · Drug Quality Assurance797945
June 30, 2011VAIAnimal Drugs & Feeds, Human Drugs · Monitoring of Marketed Animal Drugs, Feed, and Devices732530
December 11, 2009VAIAnimal Drugs & Feeds, Human Drugs · Monitoring of Marketed Animal Drugs, Feed, and Devices630720
FDA documents

Form 483s (3)

  • Form 483s · January 31, 2023
  • Form 483s · January 28, 2020
  • Form 483s · December 6, 2017

EIRs (2)

  • EIRs · January 28, 2020
  • EIRs · December 6, 2017
People (6)
Santiago Gallardo Johnson
Person
Marcus F. Yambot
Person
Doris A. Flores
Person
Vicky Gorum
Person
James Kavanaugh
Person
Anil D’Souza
Person
Related Companies (10)

Companies with similar regulatory profiles, compliance history, and operations.

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Galbraith Laboratories Inc
Nitto Avecia Pharma Services, Inc.
Alliance Technologies, LLC
ChemWerth Pharmaceutical Technology (Shanghai) Co., LTD
SGS North America Inc.
American Regent, Inc.
New Jersey Laboratories
Boston Analytical, Inc.
Encompass Pharmaceutical Services Inc.
Company Information

Name

Tolmar, Inc.

FEI Number

3006218434

Address

701 Centre Ave, Fort Collins, Colorado 80526, United States

Country

United States

ID: 0f03b95a-a7e1-4a49-a5f7-5f6842df7d92

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