FIRM FALSIFIES MICROBIAL DATA Canton Laboratories, India was found to have reported analytical results without having performed the testing. C of A’s stated that the data conformed to specifications; however, multiple personnel confirmed that the testing was not performed. Similar data was observed in July 2008 with other testing. Please read below to learn more about … [Read more...]
BAXTER HEALTHCARE CORP RECEIVES WARNING LETTER (05/31/13) — PART III
REPEAT VIOLATION CITES CRITICAL DEFECTS THAT CAN IMPACT PRODUCT STERILITY AND STABILITY The FDA recently audited two Baxter Healthcare facilities to include Marion, NC (November 7 to 16,2012) , and Jayuya, Puerto Rico (March 13, 2013 to April 19, 2013). Their Investigators identified significant violations of current good manufacturing practice (CGMP) regulations … [Read more...]
