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Dabur India says US FDA issues import alert for Silvassa plant drugs
Dabur India said the United States Food and Drug Administration (USFDA) issued Import Alert 66-40 for drugs made at part of its Silvassa facility after an inspection flagged data integrity and maintenance deficiencies.
Dabur India shares in focus after US FDA places drugs from Silvassa plant under import alert. Here’s why
Dabur India shares are set to be in focus after the US FDA issued an import alert on drugs manufactured at its Silvassa plant, citing data integrity lapses. The company said the impact is limited to a small portion of operations, while broader business and domestic sales remain unaffected.
US drug regulator issues import alert for drugs made at a Dabur India plant
The US Food and Drug Administration has placed Dabur India's factory on an import alert. This action follows an inspection that revealed significant issues with data integrity and factory maintenance. Critical manufacturing records were reportedly falsified. Live birds and droppings were also found in a raw material warehouse.
U.S. drug regulator flags data integrity, maintenance lapses at Dabur India plant
The U.S. FDA has identified significant data integrity and manufacturing lapses at a Dabur India plant following a January inspection. Findings revealed risks of microbiological contamination, falsified records, and the presence of live birds and droppings in a raw material warehouse. Management also failed to review production records before batch release.