Alkem Laboratories on Friday said it has not received any observations from the United States Food and Drug Administration for its Daman facility. The USFDA had conducted the inspection from January 14 to 18. It may be recalled that in response to the detailed corrective and preventive action (in December 2018) for the company’s St Louis plant, the USFDA had closed the inspection report. In March 2018, the USFDA had issued Form 483, containing just one observation.
What to watch. USFDA nod may boost Alkem Laboratories
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January 18, 2019 16:10