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. Sandoz GmbH
483
•Sandoz GmbH•January 12, 2023

FDA 483 - Sandoz GmbH - January 12, 2023

Record Details

An FDA inspection of Sandoz GmbH in Langkampfen, Austria, a pharmaceutical manufacturer, revealed two significant deficiencies. The firm failed to adequately establish procedures for verifying the effectiveness of corrective and preventive actions (CAPA) and for properly investigating product complaints, specifically concerning malfunctions of Hyrimoz. These issues indicate a moderate level of non-compliance with quality system requirements.

Company
Sandoz GmbH
Inspection date
January 12, 2023
Product type
drugs
Office
Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person
  • Maryam Tabatabaie (issuing_officer)
View Company Profile

ID · 16d4f5ca-64b0-4d7e-9783-321517445f81

Other documents for Sandoz GmbH
  • 483 - 2018-02-20February 20, 2018
  • 483 - 2016-07-05July 5, 2016
  • 483

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

KeyPedia

ChatGPT

Claude

Perplexity

Grok

Copilot

Document or profile

One record shows the event. A profile shows the pattern.

Buy this document for the source file and details behind this single event.

Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.

Explore Sandoz GmbH
KeyPedia
Regulatory Data Transformed
Stay in the loop

KRA score changes, company updates and news. About monthly, unsubscribe anytime.

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 KeyPedia™ | Global Key Solutions Corp. All rights reserved.