Dabur India Limited
Form 483 issued December 6, 2019 · Silvassa, India
- Inspection
- Dec 2 – Dec 6, 2019
- Investigator
- Truong X. Nguyen
- Observations
- 2
- Pages
- 2
- FEI number
- 3001413302
In short: On December 6, 2019, FDA issued a Form 483 with 2 observations to Dabur India Limited in Silvassa, India (FEI 3001413302) after an inspection that ran Dec 2 – Dec 6, 2019. The investigator was Truong X. Nguyen. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.68(b) (1×) · 211.22(d) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 02
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Truong X. Nguyen
20 documents · 2011–2026
Cites 211.22(d) (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in California.
The firmDabur India Limited history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.68(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Dabur India Limited?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Dabur India Limited?
Truong X. Nguyen is named on this Form 483, for the inspection of Dec 2 – Dec 6, 2019. Each investigator has a profile showing what they cite most.
When was Dabur India Limited inspected by FDA?
The inspection ran Dec 2 – Dec 6, 2019, and the Form 483 is dated December 6, 2019.
How do I get the full Form 483 for Dabur India Limited?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.