The U.S. Food and Drug Administration (FDA) inspected manufacturing facilities,  Changzhou Jintan Qianyao Pharmaceutical Raw Materials, from February 13-17, 2017. As a result of significant deviations from current good manufacturing practice (CGMP), the FDA placed the firm on Import Alert 66-40 on May 4, 2017. Subsequent to … [Read more...]
FDA INSPECTION (Medisca) INITIATED FOR APIs FOLLOWING RECEIPT OF REPORTS FOR SERIOUS ADVERSE EVENTS (112515)
COMMENT:  Rarely does one observe such a flagrant number of mislabeled Active Pharmaceutical Ingredients (API) noted within a Warning Letter (Click Here). In this Warning Letter, two of six samples of L-Citrulline repackaged for distribution to Pharmacies for use in compounding were tested by the FDA found to not be as labeled. The firm … [Read more...]
PAN DRUGS LTD, INDIA, RECEIVES WARNING LETTER (090215) FOLLOWING THE RECEIPT OF AN IMPORT ALERT
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...]
VUAB PHARMA, CZECH REPUBLIC, RECEIVES WARNING LETTER (MAY 27, 2015)
Objectionable Anaerobe Found During Customer Sampling During the FDA’s inspection of VUAB Pharma a.s., Vltayska 53, Roztoky, Czech Republic, from June 09, 2014, through June 13, 2014, an investigator from the U.S. Food and Drug Administration (FDA) identified significant deviations from current good manufacturing practice (CGMP) for the manufacture of active … [Read more...]
TRIFARMA S.p.A. (ITALY) RECEIVES WARNING LETTER (070714)
LETTER IS SIMILAR TO ONE RECEIVED BY CERIANO LAGHETTO PLANT (11/13) The FDA inspected the Trifarma S.p.A. pharmaceutical manufacturing facility, located at Via Pavese 2, Rozzano, Italy from January 27 – 29, 2014. They identified significant deviations from current good manufacturing practice (CGMP) for the manufacture of active pharmaceutical … [Read more...]
