3 weeks ago
USFDA Warns Dabur India Over Manufacturing Lapses at Silvassa Plant
The US Food and Drug Administration, the agency in America that makes sure medicines are safe, sent a warning letter to a big Indian company called Dabur.
The letter is about Dabur's medicine-making factory in a town called Silvassa in India.
Inspectors visited the factory and found many problems with how it made medicines.
They found that a logbook about the machines did not list some medicines that were sold in America.
They also found that some test records were missing and that equipment was not cleaned properly.
The regulators said the medicines made there could be considered 'adulterated,' which means not up to standard.
Because of this, the agency stopped some Dabur medicines from being brought into America.
Dabur said it would fix the problems by retraining workers and improving its paperwork.
The company said its business in India is not affected and the factory is still open.
Dabur also moved some production to its Baddi facility while it works with the regulators.
The USFDA issued a warning letter to Dabur India over serious manufacturing and quality control lapses at its pharmaceutical facility in Silvassa.
The regulator cited data integrity failures, including an allegedly falsified equipment usage logbook that omitted details of over-the-counter products sold in the US.
The USFDA said the facility failed to meet current good manufacturing practice (CGMP) standards, making products manufactured there liable to be considered 'adulterated'.
The USFDA placed drugs from the facility under Import Alert 66-40 effective June 5, 2026, and Dabur initiated a voluntary recall of selected products on June 2, 2026.
Dabur said the warning affects only a small private-label part of the plant and that operations continue, but the USFDA called its initial response inadequate.
- Who
- The US Food and Drug Administration (USFDA) issued the warning letter to Dabur India, addressed to Global CEO Mohit Malhotra.
- What
- A warning letter citing CGMP violations, data integrity failures and manufacturing control deficiencies, with products from the Silvassa facility deemed 'adulterated' and placed under Import Alert 66-40.
- Where
- Dabur's pharmaceutical manufacturing unit in Silvassa, Dadra and Nagar Haveli and Daman and Diu, India.
- When
- The inspection ran between January and 16 December 2026; the warning letter is dated 24 July 2027, following a teleconference on May 13, 2026 and a voluntary recall initiated on June 2, 2026.
- Why
- The facility failed to meet current good manufacturing practice (CGMP) standards under the US Federal Food, Drug and Cosmetic Act.
Dabur India
USFDA (Regulator)
Severity and Business Impact
Dabur India
The warning concerns only a small part of the plant relating to private label, which generates insignificant revenue; the Silvassa plant continues operations and the India business is unaffected.
USFDA (Regulator)
The USFDA found serious systemic violations including data integrity failures, deemed products 'adulterated', and placed all drugs from the facility under Import Alert 66-40.
Adequacy of Corrective Response
Dabur India
Dabur committed to corrective steps including employee retraining, improved documentation and stronger cleaning validation, and later submitted a revised response to the USFDA.
USFDA (Regulator)
The USFDA described the initial response as inadequate, saying the proposed measures did not sufficiently address broader systemic issues involving quality assurance and data integrity.
Scope of Product Recall
Dabur India
Dabur initiated a voluntary recall of selected products from the US market as recommended by the regulator.
USFDA (Regulator)
The USFDA noted that not all affected products had been recalled.
Key facts
- Regulator
- US Food and Drug Administration (USFDA)
- Company
- Dabur India
- Facility Location
- Silvassa, Dadra and Nagar Haveli and Daman and Diu, India
- Letter Addressed To
- Global CEO Mohit Malhotra
- Warning Letter Date
- 24 July 2027
- Inspection Period
- January to 16 December 2026
- Import Alert
- 66-40, effective June 5, 2026; voluntary recall of selected products initiated June 2, 2026
- Company Response
- Revised response submitted with corrective measures; initial response deemed inadequate by USFDA
Quotes
Mohit Malhotra
Global CEO of Dabur India
“"The Silvassa plant continues to be operational. This order concerns only a small part of our plant in relation to private label, which generates insignificant revenue for the company. Moreover, production of some part has already been shifted to our Baddi facility, and we do not anticipate any significant disruption to operations or business performance."”
livemint.com
Sources
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