LEARN OF FDA's CURRENT THINKING REGARDING AUDITING ISSUES The FDA recently released a new DRAFT Guidance for Industry on July 12, 2013 that is entitled "Circumstances that Constitute Delaying, Denying, Limiting or Refusing a Drug Inspection". The Draft Guidance for Industry uses examples that illustrate the most common situations that the FDA has encountered and provides very … [Read more...]
WHO, TGA AND MHRA JUSTIFY RELEASE OF RANBAXY’S PRODUCTS — EVEN AFTER FDA ISSUES $500 MILLION FINE
WHAT IS THE MEANING OF “ADULTERATEDâ€? Pharma Evolution just released an "abridged" Blog, "WHO, TGA & MHRA: Just What Does the Word 'Adulterated' Mean?" (see below).() Should you wish to read and comment on this abridged version, please go to the location listed above. To view the total Blog, continue reading … [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...]
BAXTER HEALTHCARE CORP RECEIVES SINGLE WARNING LETTER FOR TWO LOCATIONS (05/31/13) — PART II
WHEN IS PARAMETRIC RELEASE USING TERMINAL STERILIZATION NOT STERILIZATION 3. "Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to … [Read more...]
BAXTER HEALTHCARE CORP RECEIVES SINGLE WARNING LETTER FOR TWO LOCATIONS (05/31/13)
TOTAL MANAGEMENT COLLAPSE OF TERMINAL STERILIZATION OCCURS AT THE MARION, NC FACILITY BASED UPON FDA FINDINGS 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 … [Read more...]
