The FDA inspected Micro Labs Limited, located at Plot No. S-155 to S-159, Phase III, Verna Industrial Estate, Verna, India, between May 5-10 and 12-13, 2014. Investigators from the U.S. Food and Drug Administration (FDA) identified significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, Title 21, Code of Federal … [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...]
FAILURE TO PROTECT COMPUTERIZED DATA – A REMINDER OF SANDOZ AND CEPHAZONE PHARMA’S FDA WARNING LETTER ISSUES
POSH CHEMICALS PRIVATE LTD RECEIVES FDA WARNING LETTER (8/2/13) During the timeframe of March 3-8, 2013 the FDA inspected Posh Chemicals Private Ltd, Hyderabad, India. A total of three Observations were received. Of particular note is Observation 1 which is similar to Observations from several other Warning Letters to include Sandoz and … [Read more...]
