From USFDA
Alkem Laboratories has been issued an Establishment Inspection Report by the United States Food and Drug Administration for its Daman facility which was inspected in September 2016. The inspection has now been closed by USFDA.The USFDA had inspected the Daman Formulations facility from 20 September to 29 September 2016 and had issue Form 483 with 13 observations. Post this, the Company had submitted a detailed corrective and preventive action (CAPA) plan to the regulator within stipulated timelines. The USFDA reviewed the CAPA and has found them acceptable.
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