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Barry A. Friedman, PhD LLC

FDA Regulatory Compliance for the Pharmaceutical, Biotechnology and Medical Device Arenas

PAN DRUGS LTD, INDIA, RECEIVES WARNING LETTER (090215) FOLLOWING THE RECEIPT OF AN IMPORT ALERT

October 7, 2015 By Barry Friedman 1 Comment

An inspection of Pan Drugs LTD, Gujarat, India from July 14-18, 2014 lead to serious deviations that caused their APIs to be adulterated in that the methods used in, or the facilities or controls used for, their manufacture, processing, packing or holding do not conform to, or are not operated or administered in conformity with cGMP. COMMENT: Pan Drugs was placed on … [Read more...]

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