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| Exchange Received Time 05/10/2019 11:26:03 Exchange Disseminated Time 05/10/2019 11:26:09 Time Taken 00:00:06 | We would like to inform you that in relation to an inspection conducted by USFDA between Apr 15 to 20, 2019 at the company's Baddi facility in HP,India,the company had earlier informed that the inspection was classified as 'Official Action Indicated' vide a letter by USFDA. With regards to the same inspection, USFDA has now issued a 'Warning Letter' to the Baddi facility. The company is committed to work along with USFDA to implement all the necessary corrective actions required to address the concerns raised in the letter & is in the process of preparing a detailed response to USFDA within 15 working days.
We believe that the existing manufacturing & the sale of products from this facility will not be impacted. Baddi facility is expected to contribute USD 30mn in total sales for this FY which is approx 7% of total US sales.There are no major pending approvals from this facility in the next 12 months.There will be no financial impact on the organisation on account of this development. |
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