Attention www.globalkeysolutions.net is now www.keypedia.com, read the full press release here.
KeyPedia LogoKeyPedia Icon
  1. Home
  2. /
  3. Records
  4. /
  5. 483
  6. /
  7. Monarch PCM, LLC
483
•Monarch PCM, LLC•February 6, 2018

FDA 483 - Monarch PCM, LLC - February 06, 2018

View on Dashboard

Your cart

Your cart is empty.

Browse public document pages and click Buy this document. We'll ask for your email at checkout, no account needed up front.

Browse documents

Discuss this record with AI

ChatGPT

Claude

Perplexity

Grok

Copilot

Record Details

An FDA inspection of Monarch PCM LLC in Fort Worth, TX, a drug manufacturer, revealed a significant lapse in quality control procedures. The firm failed to establish written procedures for Annual Product Reviews (APRs) and did not conduct these reviews for its Over-the-Counter human drugs in 2017. This indicates a serious deficiency in ensuring ongoing product quality and compliance.

Company
Monarch PCM, LLC
Inspection Date
February 6, 2018
Product Type
Drugs
Office
Dallas District Office
Person
  • Lisa Whitt (Cornerstone Brands Inc.)
Open in Dashboard

ID · fb2ba290-6480-40a9-9455-e9d1a3b184a4

footer
Global Key Solutions
Regulatory Data Transformed
Contact
New York Office:
370 Jay Street 7th Floor
Brooklyn, NY 11201
Scranton Office:
Scranton Enterprise Center, Suite 217
201 Lackawanna Avenue
Scranton, PA, 18503
🇺🇸+1 917-789-5099
🇪🇺+48 532-447-507
info@globalkeysolutions.net
Quick Links
HomePlatform OverviewMedia
KeyPedia™ Lite
Browse HubDatabase DirectoryRecordsCompaniesOfficesPeopleCareersAbout UsFounding TeamMeet Our ExpertsPartners
Legal & Ethics
Privacy PolicyTerms of ServiceOur Values & MissionCode of Ethics & AI Policy
©2026, Global Key Solutions All rights reserved.