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Alkem's Baddi manufacturing facility receives 3 observations from US FDA

US FDA had conducted an inspection at Alkem's Baddi facility from March 2-10, 2017

BS B2B Bureau  |  Mumbai 

Alkem's Baddi manufacturing facility receives 3 observations from US FDA

Laboratories, manufacturer of generics, formulations and active ingredients (APIs), has received three 483 observations for its Baddi manufacturing facility in Himachal Pradesh from the US Food & Drug Administration (FDA). An is issued to firm management at the conclusion of an inspection when investigators have observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act of the US.

Observations were issued by the US after it conducted an inspection at Alkem’s Baddi facility from March 2-10, 2017.

“The company has received the inspection report which contains three 483 observations. The company shall put together a detailed response with adequate corrective and preventive measures to address the US observations and the same is proposed to be filed within the timeline stipulated by US FDA,” said in a BSE filing on Friday.

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Alkem's Baddi manufacturing facility receives 3 observations from US FDA

US FDA had conducted an inspection at Alkem's Baddi facility from March 2-10, 2017

US FDA had conducted an inspection at Alkem's Baddi facility from March 2-10, 2017
Laboratories, manufacturer of generics, formulations and active ingredients (APIs), has received three 483 observations for its Baddi manufacturing facility in Himachal Pradesh from the US Food & Drug Administration (FDA). An is issued to firm management at the conclusion of an inspection when investigators have observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act of the US.

Observations were issued by the US after it conducted an inspection at Alkem’s Baddi facility from March 2-10, 2017.

“The company has received the inspection report which contains three 483 observations. The company shall put together a detailed response with adequate corrective and preventive measures to address the US observations and the same is proposed to be filed within the timeline stipulated by US FDA,” said in a BSE filing on Friday.
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Alkem's Baddi manufacturing facility receives 3 observations from US FDA

US FDA had conducted an inspection at Alkem's Baddi facility from March 2-10, 2017

Laboratories, manufacturer of generics, formulations and active ingredients (APIs), has received three 483 observations for its Baddi manufacturing facility in Himachal Pradesh from the US Food & Drug Administration (FDA). An is issued to firm management at the conclusion of an inspection when investigators have observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act of the US.

Observations were issued by the US after it conducted an inspection at Alkem’s Baddi facility from March 2-10, 2017.

“The company has received the inspection report which contains three 483 observations. The company shall put together a detailed response with adequate corrective and preventive measures to address the US observations and the same is proposed to be filed within the timeline stipulated by US FDA,” said in a BSE filing on Friday.

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Business Standard
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