The US Food and Drug Administration (FDA) has issued an import alert for drugs manufactured at Dabur India’s factory in India’s western region of Dadra and Nagar Haveli. This action was taken after the FDA inspected the factory and found data integrity and maintenance lapses.

Inspection Findings

The inspection revealed that critical manufacturing records were falsified to conceal that equipment meant to make certain products had been used for multiple other products. Additionally, a live bird and bird droppings were found in the raw material warehouse, about 30 feet from packaging materials.

Dabur is one of India’s oldest and largest consumer goods companies, supplying a range of over-the-counter and consumer health products in the US, including cough and cold rubs, antifungal creams, pain relief gels, and oral care products.

The company stated that the FDA action does not have any financial or operational impact and that domestic products are not affected by the order. Dabur is engaging with the US regulator by providing corrective and preventive action plans and taking actions to fix the identified gaps.

Original reporting: Appleton, WI News Feed (HLL/CB) — read the source article.