Phoenix Innovative Healthcare Manufacturers Private LimitedSeptember 27, 2024

FDA 483 - Phoenix Innovative Healthcare Manufacturers Private Limited - September 27, 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 Phoenix Innovative Healthcare Manufacturers Private Limited

Record Details

Phoenix Innovative Healthcare Manufacturers Private Limited, a drug manufacturer in Navi Mumbai, India, was inspected and received a Form 483 with six observations. The inspection revealed significant deficiencies in laboratory controls, quality unit investigations, sample retention, production record-keeping, yield reconciliation, and equipment suitability. These issues indicate a lack of robust quality systems and control over manufacturing processes.

Company: Phoenix Innovative Healthcare Manufacturers Private Limited
Inspection Date: September 27, 2024
Product Type: Drugs
Office: Office of Inspections and Investigations
Person: Steven A. Brettler (Consumer Safety Officer)

Open in Dashboard

ID · 56d07290-83a1-465f-83a2-1b8bde6546f7