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| Exchange Received Time 26/11/2019 09:36:05 Exchange Disseminated Time 26/11/2019 09:36:16 Time Taken 00:00:11 | Vide our letter dated 24th August, 2019, we had intimated to you about US FDA inspection of our Piparia (Silvassa) formulations manufacturing unit from 19th August, 2019 to 23rd August, 2019 which resulted into 3 observations under USFDA Form 483.
We have now received a communication from US FDA that they have determined the inspection classification of this manufacturing facility as "Official Action Indicated (OAI)" and that that this facility is considered to be in an unacceptable state of compliance with regards to current good manufacturing practice (CGMP).
Since this manufacturing facility is already under US FDA import alert and presently not doing any US business, this will have no impact on Company''s current on-going business
activities. |
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