# FDA 483 - Dabur India Limited - December 06, 2019

Source: https://www.globalkeysolutions.net/records/483/dabur-india-limited/b051d465-26ab-460a-a4bb-54b736b2d02b

> FDA 483 for Dabur India Limited on December 06, 2019. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Dabur India Limited
- Inspection Date: 2019-12-06
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: 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.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/truong-x-nguyen/8f3aed17-0507-4272-a3b8-9188d761faed)

Company: https://www.globalkeysolutions.net/companies/dabur-india-limited/2ebc1b41-4c7c-4d04-80ff-a73a05cd6920

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1