Sunday, 8 April 2018

Audit updates: The U. S. drug regulator is conducting a surprise audit at Alkem Laboratories Ltd.’s largest facility in Daman

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The U. S. drug regulator is conducting a surprise audit at Alkem Laboratories Ltd.’s largest facility in Daman, Gujarat, two people aware of the development told BloombergQuint requesting anonymity.

The U. S. Food and Drug Administration officials began inspecting the site yesterday, which is expected to go on for another four to five days, the two people quoted above said. The officials are mainly auditing the quality control practices and production line of the Mumbai-based drug maker.
Emails sent to Alkem Labs remained unanswered, while the U.S. FDA said they cannot confirm, deny or comment on enforcement actions.
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