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Alkem Labs gets 8 USFDA observations for St Louis facility


Alkem Labs gets 8 USFDA observations for St Louis facility
The United States Food and Drug Administration (USFDA) had issued eight observations after inspecting the company’s manufacturing plant at St Louis from January 14 to February 5 this year, Alkem Labs said in a filing to BSE.
 
New Delhi: Drug firm Alkem Laboratories Friday said it has received a letter from the US health regulator asking not to manufacture a particular product at its St Louis facility till a final decision is taken.
The United States Food and Drug Administration (USFDA) had issued eight observations after inspecting the company’s manufacturing plant at St Louis from January 14 to February 5 this year, Alkem Labs said in a filing to BSE.
 

The company had submitted a detailed response to the eight observations that it had received during the pre-approval inspection for the product, it added.

The company, however, did not provide any details about the product.

“The company has now received a letter from USFDA informing that the manufacturing of the said product be withheld until the completion of the final evaluation by the USFDA and the final decision of USFDA shall be communicated to the company accordingly,” the drug firm said.

Read Also: Alkem Labs gets EIR from USFDA for its Daman facility

The said product is not being manufactured as it is awaiting approval from USFDA, it added.

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Source: PTI
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