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...]
APOTEX INC RECEIVES WARNING LETTER FOR MULTIPLE CANADIAN SITES (2/21/13) PART II
FDA INVESTIGATOR FINDS INACCURATE REPORTING OF MICROBIOLOGICAL DATA The FDA, during August and October 2012 inspected two Apotex, Inc. sites. This Blog only discusses the facilities located at 150 Signet Drive, Toronto, Canada. The U.S. Food and Drug Administration (FDA) identified significant violations of current good manufacturing practice (CGMP) … [Read more...]
