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Jan 03, 2018 10:59 AM IST | Source: Moneycontrol.com

Dr Reddy’s cracks on buzz of issues raised in EIR for Duvvada plant

According to a report on CNBC-TV18, an EIR has been issued to the company’s Duvvada facility. The report further states that Duvvada facility status continues to be classified as official action initiated (OAI).

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Dr Reddy’s Laboratories fell over 4.5 percent intraday as investors reacted to the receipt of establishment inspection report (EIR).

According to a report on CNBC-TV18, an EIR has been issued to the company’s Duvvada facility. The report further states that Duvvada facility status continues to be classified as official action initiated (OAI).

In pharmaceuticals parlance, OAI means a regulatory and / or admin sanctions by the drug regulator are initiated.

The channel also reported that 13 US FDA observation details were given to the unit in February-March 2017.

It must be noted that the plant is an injectable one, which is 5-8 percent of US sales and has been under a warning letter since 2015.

What does the EIR include?

- Feb-Mar 2017 Inspection Had Numerous Items Not Corrected From 2015 Inspection

- Repeated Instances Of False/Misleading Statements By Staff Discussed Wit management

- Training Provided Was Not Effective In Eliminating Repeated Staff Errors

- Appropriate Action Not Taking For Out Of Specification Result

The company responded to the development and said that a ‘cultural transformation’ was being undertaken at Duvvada. Steps are being taken to solve employee problems.
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