Dabur India Limited
Form 483 issued January 16, 2026 · Dadra And Nagar Haveli, India
- Inspection
- Jan 12 – Jan 16, 2026
- Investigator
- Rafeeq Habeeb
- Observations
- 7
- Pages
- 9
- FEI number
- 3001413302
In short: On January 16, 2026, FDA issued a Form 483 with 7 observations to Dabur India Limited in Dadra And Nagar Haveli, India (FEI 3001413302) after an inspection that ran Jan 12 – Jan 16, 2026. The investigator was Rafeeq Habeeb. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 6 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
The quality control unit lacks authority to review production records to assure that no en ors…
- 02
Procedures for the cleaning and maintenance of equipment are deficient regarding the protection of clean equipment…
- 03
Drug product production and control records, are not reviewed and approved by the quality control unit…
- 04
Written procedures are not established and followed for evaluations conducted at least annually to review records…
This inspection in context
Rafeeq Habeeb
20 documents · 2020–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
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 211.22(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Dabur India Limited?
FDA listed 7 observations on this Form 483, mostly about quality system, facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected Dabur India Limited?
Rafeeq Habeeb is named on this Form 483, for the inspection of Jan 12 – Jan 16, 2026. Each investigator has a profile showing what they cite most.
When was Dabur India Limited inspected by FDA?
The inspection ran Jan 12 – Jan 16, 2026, and the Form 483 is dated January 16, 2026.
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.