FDA Warns Lupin Subsidiary, Aesthetics Firm

Posted By American Med Spa Association, Friday, July 9, 2021

The US Food and Drug Administration (FDA) sent warning letters to generic drugmaker Lupin, Inc. over good manufacturing practice (GMP) issues at one of its US-based subsidiaries’ facilities and medical aesthetics firm Aquavit Pharmaceuticals for marketing two devices without approved applications.

In its 11 June warning letter to Lupin subsidiary Novel Laboratories, Inc., the U.S. Food and Drug Administration (FDA) cites the firm for three GMP violations at its Somerset, New Jersey, facility.
FDA notes that the issues cited in the warning letter include repeat violations cited in recent warning letters concerning three Lupin facilities in India.

The warning letter follows a nearly two-months-long inspection that occurred from 10 September to 5 November 2020.

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