Alkem Laboratories announced that with reference to the USFDA inspection of its facility at St. Louis, USA, the company had submitted a detailed response to the eight (8) Form 483 observations that it had received during a pre-approval inspection for a product at the Company's manufacturing facility located at St. Louis, USA.
The Company has now received a letter from the 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 the USFDA shall be communicated to the Company accordingly. It is to be noted that the said product is not being manufactured at this time as it is awaiting approval from US FDA.
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