Par Formulations Private LimitedMarch 26, 2024

FDA 483 - Par Formulations Private Limited - March 26, 2024

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 Par Formulations Private Limited

Record Details

Par Formulations Private Limited in Dhar, India, was inspected by the FDA from March 18-26, 2024. The inspection revealed significant deficiencies in procedures designed to prevent microbiological contamination of sterile drug products. These issues included failures in aseptic filling operations, inadequate cleaning procedures, shortcomings in environmental and personnel monitoring, unvalidated equipment, and incomplete laboratory qualification.

Company: Par Formulations Private Limited
Inspection Date: March 26, 2024
Product Type: Drugs
Office: Office of Inspections and Investigations
Person: Teresa I. Navas

Open in Dashboard

ID · fb303e13-24ca-4032-a171-13e6cc9963cb