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...]
Indian Mexican API Facilities Cited by FDA in Warning Letter
Dr. Reddy's Laboratories Found in Non-Compliance and In Receipt of an Import Ban Comment Dr Reddy's Mexico facilities were inspected between November 8-11, 2010. During the audit the FDA identified significant deviations from CGMP for the manufacture of APIs. These deviations caused the APIs to be adulterated. A response dated December 1, 2010, received by the Agency, … [Read more...]
