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•United States

Monarch PCM, LLC, Fort Worth, TX – FDA Inspections

Inspection records and compliance data for Monarch PCM, LLC in Fort Worth, Texas. 3 FDA inspections on record (1 OAI), 1 Form 483, 1 warning letter, last inspected July 19, 2024.

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Company Profile

This profile covers Monarch PCM, LLC based in Fort Worth, Texas, United States.

FDA Inspection History

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

First inspected February 6, 2018. Last inspected July 19, 2024.

Most cited issue areas

  • Complete test data included in records1 inspection
  • Component - qualify supplier1 inspection
  • Conditions, controls -protect; microorganisms, contamination1 inspection

FDA inspections (3)

DateResultFDA center(s)Insp. #
July 19, 2024NAIHuman Drugs · Drug Quality Assurance1229213
August 20, 2021OAIFoods & Cosmetics, Human Drugs · Foodborne Biological Hazards1149435
February 6, 2018VAIHuman Drugs · Drug Quality Assurance1039971
FDA documents

Form 483s (2)

  • Form 483s · August 20, 2021
  • Form 483s · February 6, 2018

Warning Letters (1)

  • Warning Letters · August 20, 2021

EIRs (1)

  • EIRs · February 6, 2018
People (4)
Lisa Whitt
Person
Scott Tucker
Person
Liza L. Quiles
Person
Clinton J. Lott
Person
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Techni Med, Inc. dba The Compounder
Triangle Compounding Pharmacy Inc
Stewart Compounding Pharmacy
Kathryn J. Lucas, M.D.
Frontage Laboratories, Inc.
Safrel Pharmaceuticals LLC
Company Information

Name

Monarch PCM, LLC

FEI Number

3012816585

Address

7333 Jack Newell Blvd N Ste 100, Fort Worth, Texas 76118, United States

Country

United States

ID: ee588fdf-02dc-4629-9dee-c06da9214f78

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