Shiva Analyticals (India) Pvt. Ltd.January 24, 2025

FDA 483 - Shiva Analyticals (India) Pvt. Ltd. - January 24, 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 Shiva Analyticals (India) Pvt. Ltd.

Record Details

An FDA inspection of Shiva Analyticals (India) Pvt. Ltd., a contract testing laboratory in Hoskote Bangaluru, revealed significant deficiencies across its quality control unit. Observations included widespread data integrity issues, inadequate analytical method validation, and a failure to thoroughly investigate discrepancies and customer complaints. These findings indicate a severe lack of oversight and adherence to cGMP principles.

Company: Shiva Analyticals (India) Pvt. Ltd.
Inspection Date: January 24, 2025
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
People: Timothy H. Vo (investigator)
Pratik S. Upadhyay

Open in Dashboard

ID · e4971176-fb62-4af2-9c59-cf6938aa5dc1