Glenmark Pharmaceuticals Inc USAMay 19, 2022

FDA 483 - Glenmark Pharmaceuticals Inc USA - May 19, 2022

View on Dashboard

Discuss this record with AI

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 Glenmark Pharmaceuticals Inc USA

Record Details

An FDA inspection of Glenmark Pharmaceuticals Inc USA revealed numerous deficiencies across its quality control, production, and laboratory operations. Key issues included a lack of authority for the quality control unit, inadequate investigation of discrepancies, and failures in maintaining sterile conditions and proper equipment. The findings indicate systemic problems in adhering to established procedures and ensuring drug product quality and safety.

Company: Glenmark Pharmaceuticals Inc USA
Inspection Date: May 19, 2022
Product Type: Drugs
Office: FDA District Office — Atlanta, Georgia
People: Adam R. Cooke (Commissioned Corps of the U.S. Public Health Service)
Steven A Brattlie
Justin A. Boyd (Research Specialist II)

Open in Dashboard

ID · 1b8b8fd4-51be-4814-beba-b692741bb894