FIRM FAILED TO ESTABLISH AND FOLLOW PROCEDURES DESIGNED TO PREVENT MICROBIOLOGICAL CONTAMINATION (21 CFR 211.113(b)) 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 … [Read more...]
WINTAC LIMITED INDIA RECEIVES FDA WARNING LETTER (022312)
CITES ASEPTIC MANUFACTURING FACILITY FOR SIGNIFICANT cGMP VIOLATIONS Specific violations observed during the inspection include, but are not limited, to the following: 1. Your firm has not established or followed appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile. Such procedures shall include validation of … [Read more...]
MERCK KGaA RECEIVES WARNING LETTER (12/15/11)
FDA INCLUDES THREE EUROPEAN FACILITIES TO INCLUDE MERCK SERONO S.A., AUBONNE, SWITZERLAND WITH MEDIA FILL ISSUES The FDA released on Wednesday, February 17, 2012 a Warning Letter that was sent to Merck KGaA on December 15, 2011. Within the Warning Letter the FDA advised Merck KGaA management of deficiencies at three separate facilities, two in Switzerland and one in Rome, … [Read more...]
REVIEW OF SELECTED OBSERVATIONS FROM BEN VENUE FDA 483 (5/25/11)
MEDIA FILL OBSERVATION GATHERS 8 "SUBOBSERVATIONS" COMMENT Enclosed are the initial four Subobservations from the audit surrounding the Media Fill Program. Where possible FDA's 2004 Aseptic Processing Guidance is referenced. OBSERVATION 3 The "Media Fill Program Parameters and Specifications" document #030-SOP-029, and the "Outlining Test Parameters and Specifications … [Read more...]
