Yet Another Form 483 Observation Issued To Dr. Reddy's


Dr. Reddy’s Laboratories received Form 483 with 2 observations from US FDA, post inspection. The 483 observations were received for its Active Pharmaceutical Ingredients plant at Srikakulam in Andra Pradesh. 

The stock of Dr. Reddy's tumbled 1.4% i.e. by Rs 34 to the 2707 level, post the news.

Earlier, in November 2015, Srikakulam along with two other units had received warning from US FDA that demanded remediation owing to some specific observations. The two other units included oncology formulations unit at Duvvada in Visakhapatnam and Miryalaguda plant in Telangana. Still Srikakulam observations were relatively lower as compared to the 13 observations issued to the other two units.

The audit conducted recently at Srikakulam unit marked the conclusion of the re-inspection at the three units, undertaken by US FDA. The corrective measures were duly taken by the Company.

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