US FDA points out manufacturing lapses at Lupin's Tarapur API plant

US FDA points out manufacturing lapses at Lupin's Tarapur API plant

• By Staff Writer

US Food and Drug Administration (US FDA) has pointed out various manufacturing lapses at drug maker Lupin's Tarapur plant in Thane, which produces active pharmaceutical ingredients (API). In a warning letter, FDA said the plant failed to establish adequate written procedures for cleaning equipment. The health regulator inspected the plant from March 22 to April 4, 2022.