Dabur India says that there is no impact on financial, operation or other activities of the company as of now
After the United States Food and Drug Administration (USFDA) flagged serious manufacturing, maintenance and data integrity lapses at Dabur India’s plant in Dadra and Nagar Haveli, the company has issued a clarification, stating that the observations concern only a small part of its manufacturing plant.
In an exchange filing, the company added that the plant situated at Silvassa, Dadra and Nagar Haveli, generates insignificant revenue for the company. The plant continues to be operational, the company pointed out.
“We are actively engaged with the USFDA on the findings of the audit and have built a robust corrective and preventive action plan to resolve the concerns raised, which has been shared with the USFDA with updates on the progress being shared regularly. We continue to implement strong controls to ensure that our quality systems are never compromised,” the company added.
Dabur India said that its products are manufactured and delivered with highest level of quality and hygiene, which is in strict compliance with applicable regulations, standards and specifications. The company said that it leverages its extensive global research and development network for enhancement of quality standards for its products.
“As of now, there is no impact on financial, operation or other activities of the company due to the above,” the company clarified. As per the USFDA unit, certain units within the facility posed contamination risks, while lapses in equipment cleaning, maintenance and quality control procedures. The agency also said that critical manufacturing records had been falsified to conceal the use of equipment for products other than those for which it was originally made.
