FDA 483 - Shiva Analyticals (India) Pvt. Ltd. - February 24, 2016
Discuss this record with AI
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.
Shiva Analyticals India Pvt. Ltd., a contract testing lab in Hoskote, India, was cited for significant deficiencies in laboratory control mechanisms and the management of data acquisition software and IT systems. The inspection revealed failures to review temperature and humidity data for storage equipment and a lack of written procedures for such reviews. Additionally, the firm exhibited inadequate data backup, undocumented user roles and permissions, unprotected data from deletion, and missing system-level audit trails for various analytical instruments.
- Person
ID · 617bf306-ae11-4cec-b73e-73262ea5e476