Lupin: FDA Audit Discovered ‘Minor’ Problems

An FDA audit of Indian drugmaker Lupin revealed four potential violations in two 483s at two of its production facilities, the company admitted in a note to the Bombay Stock Exchange last week.

While the letter does not disclose the nature of the observations following a Feb. 2 to 17 audit of the company’s Mandideep production site, it characterizes them as “minor,” saying they have been addressed and that it doesn’t expect the FDA to demand any remediation.

Lupin states that a solid dosage form plant at the site received a 483 with two observations and an API production plant at the site also received a 483 with two observations. The letter notes that two of the observations were site-wide, leading it to characterize them as a single violation.