483
Dabur India LimitedFDA 483 - Dabur India Limited - December 06, 2019
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An FDA inspection of Dabur India Limited in Silvassa revealed two significant observations. The firm failed to exercise appropriate controls over computerized systems, allowing unauthorized data deletion and lacking audit trail features on analytical instruments. Additionally, the company has not established written procedures for the quality control unit's responsibilities, including user privileges and data management for computerized systems.
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