New Delhi : The United States Food and Drug Administration (USFDA) has issued a warning letter to Canada headquartered Apotex Pharmachem over violations of manufacturing norms at its Bangalore plant.

Among the major violations cited by the USFDA was the “failure to maintain complete data derived from all laboratory tests conducted to ensure compliance with established specifications and standards” by the company.  FDA has given the company 15 working days to notify it of the specific steps that the company has taken to correct and prevent the recurrence of deviations.

(To download our E-paper please click here. The publishers permit sharing of the paper's PDF on WhatsApp and other social media platforms.)

Free Press Journal