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...]
“FDA’S CONTRIBUTION TO THE DRUG SHORTAGE CRISIS” — A HOUSE OF REPRESENTATIVES STAFF REPORT (6/15/12)
The U.S. House of Representatives Committee on Oversight and Government Reform recently published a 21 page staff report document that was highly critical of the FDA. Several of you had requested information regarding this report since you were interesting in reading the report that caused the FDA response. Enclosed below are several of the key … [Read more...]
