FDA 483 - Shiva Analyticals (India) Pvt. Ltd. - February 24, 2016

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.