March 30, 2017 / 10:11 AM / 4 months ago

BRIEF-Alkem Labs says USFDA closed inspection at API manufacturing unit at Ankaleshwar

2 Min Read

March 30 (Reuters) - Alkem Laboratories Ltd:

* Says inspection at company's API manufacturing facility located at Ankaleshwar has now been closed by US FDA

* Says company had submitted a detailed corrective and preventive action (CAPA) plan to regulator within stipulated timelines

* Says FDA issued an EIR for its API manufacturing facility at Ankaleshwar, India which was inspected in December 2016

* Says US FDA has reviewed CAPA and has found them acceptable Source text:

In furtherance to the intimation captioned 'Update on US FDA Inspection at Alkem's Ankaleshwar API Facility' dated 12th December, 2016, this is to inform you that the US FDA has issued an Establishment Inspection Report (EIR) for the Company's Active Pharmaceutical Ingredient (API) manufacturing facility located at Ankaleshwar, India which was inspected in December 2016. The inspection has now been closed by the US FDA. In response to the Form 483 issued by the US FDA, the Company had submitted a detailed corrective and preventive action (CAPA) plan to the regulator within the stipulated timelines. The US FDA has reviewed the CAPA and has found them acceptable.

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