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...]
Cobwebs On Oxygen Analyzer Foil Trans Ox During FDA Inspection
Trans Ox Citations Result in Warning Letter (June 8, 2015) During a November 13, 2014, through November 20, 2014, inspection of Trans Ox pharmaceutical manufacturing facility at 2543 Morningside Drive, Suite A, West Columbia, South Carolina, an investigator from the U.S. Food and Drug Administration (FDA) identified significant violations of current good manufacturing … [Read more...]
