Shilpa Pharma Lifesciences LimitedMarch 7, 2025

FDA 483 - Shilpa Pharma Lifesciences Limited - March 07, 2025

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 Shilpa Pharma Lifesciences Limited

Record Details

An FDA inspection of Shilpa Pharma Lifesciences Limited, an API non-sterile drug substance manufacturer in Deosugur, revealed significant deficiencies in their Quality Control unit. The firm repeatedly failed to ensure QC personnel followed approved testing procedures, leading to over one hundred human errors since January 2022. Corrective actions, including retraining, have proven ineffective in addressing these persistent issues.

Company: Shilpa Pharma Lifesciences Limited
Inspection Date: March 7, 2025
Product Type: Drugs
Office: Office of Inspections and Investigations
Person: Ankur C. Patel

Open in Dashboard

ID · 42ddd310-1e39-40d2-9c94-bc5f9e569e01