Solara Active Pharma Sciences LimitedAugust 29, 2025

FDA 483 - Solara Active Pharma Sciences Limited - August 29, 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 Solara Active Pharma Sciences Limited

Record Details

Solara Active Pharma Sciences Limited, an API manufacturer in New Mangalore, India, was cited for significant quality system deficiencies during an FDA inspection. The firm's Quality Unit failed to adequately investigate product complaints involving foreign particle contamination and neglected to review multiple pest alerts. Additionally, the facility lacked proper handwashing facilities with hot water and soap in manufacturing areas.

Company: Solara Active Pharma Sciences Limited
Inspection Date: August 29, 2025
Product Type: Drugs
Office: Office of Inspections and Investigations
Person: Steven A. Brettler (Consumer Safety Officer)

Open in Dashboard

ID · 1238ab6a-8a14-40fd-a49d-47cdf16a045b