Lupin falls 4% as US FDA issues observations to Pithampur unit

Failure to review unexplained discrepancy, among others, included in the observations.

Lupin’s shares fell 4 percent as investors turned wary of observations issued by the US Food and Drug Administration for its Pithampur unit.

The stock touched an intraday high of Rs 844.35 and an intraday low of Rs 811.00.

According to a report by CNBC-TV18, US FDA’s observations for Pithampur unit include a few observations.

The observations include:

- Failure to review unexplained discrepancy

- Written records do not include findings and follow-up

- Employees engaged in manufacturing, packaging and processing lack training

- Appropriate controls are not exercised on computers or related systems

- Equipment used in manufacturing, processing, and packaging is not of appropriate design

- Established laboratory control mechanisms are not documented.

At 09:52 hrs Lupin was quoting at Rs 824.00, down Rs 17.95, or 2.13 percent, on the BSE.

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