STARTS THURSDAY, MARCH 19, 2015 The United States Pharmacopeia (USP) contains a number of chapters relating to microbiology within its General and General Information Chapters. These Chapters present information that relate to both non-sterile and aseptic processing. Several of these chapters have been recently updated and all have been updated since 2009. Each of these … [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...]
REGULATORY COMPLIANCE/EXPERT MICROBIOLOGICAL WITNESS CONSULTATION
Regulatory Compliance -- Form FDA 483/Warning Letters With the advent of only 15 calendar days to respond to regulators following a Form FDA 483 or Warning Letter, it is incumbent upon the recipients of these to use the time most productively to minimize any further regulatory actions. Understanding the Observation becomes the initial step. Unless the individuals are … [Read more...]
