FDA hands a warning letter to a Lupin subsidiary after failing to maintain cleanliness once again
From India to NJ, the core of the FDA’s instructions to Lupin subsidiary Novel Laboratories were the same: establish proper cleaning and process validation guidelines at your manufacturing sites. And after failing to do so for the third time in four years, the company has received a warning letter.
Drug residue on tablet presses and a failure to validate the manufacturing process after equipment changes were just two of the issues raised by the FDA after an inspection of a Novel Laboratories plant that led to the June 11 letter.
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