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483
•Dabur India Limited•December 6, 2019

Dabur India Limited – FDA 483, Dec 6, 2019

Record Details

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.

Company
Dabur India Limited
Inspection date
December 6, 2019
Product type
drugs
Office
Office of Biological Products Operations - Division I
Person
  • Truong X. Nguyen (Investigator)
View Company Profile

ID · b051d465-26ab-460a-a4bb-54b736b2d02b

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