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...]
NEW ENGLAND COMPOUNDING CENTER RECEIVES FDA 483 (10/26/12)
FDA INVESTIGATORS CONFIRM CONTAMINATION IN 50 OF 50 VIALS TESTED COMMENT The FDA issued its initial Form FDA 483 regarding the New England Compounding Center located in Framingham, MA. The eight page, five item 483 describes the initial findings of their audit. The Company now has 15 business days to submit its response to the FDA. Of … [Read more...]
NEW ENGLAND COMPOUNDING CENTER (NECC) POTENTIALLY CONTAMINATED MEDICATION: FUNGAL MENINGITIS OUTBREAK
Out of an abundance of caution, FDA is taking the additional step of recommending that health care professionals and consumers not use any product that was produced by NECC at this time. [UPDATED 10/06/2012] On October 4, 2012, the CDC and FDA recommended that all health care professionals cease use and remove from their pharmaceutical inventory any product produced by the New … [Read more...]
FDA (CBER) ISSUES MULTI-NATIONAL WARNING LETTER TO SANOFI PASTEUR (07/12/12)
COMMENT The FDA published last Wednesday (July 25, 2012) a multipage Warning Letter to Sanofi Pasteur’s facilities in Toronto, Canada and Marcy l’Etoile, France. This Warning letter followed extensive GMP audits of both facilities between March 19 – April 2, 2012 (France) and April 10 and April 25, 2012 (Canada). Within the Warning Letter are issues relating to the … [Read more...]
USP FAQ – HOW ARE MICROBIAL LIMITS AND OBJECTIONABLE (SPECIFIED) MICROORGANISMS DETERMINED
COMMENT A question that is frequently asked during consulting, webinars and seminars is how does one choose appropriate microbial limits, especially with non-sterile raw materials, intermediates and final products. The USP Microbiological Expert Committee has considered this issue and provided Guidance. Please read their considerations below. In determining the appropriate … [Read more...]
