IS THIS THE NEW “POSTER CHILD†FOR NON-COMPLIANCE? On Friday, August 16, 2013 the FDA issued a News Release wherein it reminded “health care providers not to use sterile products from NuVision Pharmacyâ€. The FDA indicated that the rationale behind the News Release was because the … [Read more...]
WOCKHARDT LIMITED, AURANGABAD, INDIA RECEIVES WARNING LETTER (7/18/13)
FIRM IS CITED FOR WITHOLDING TRUTHFUL INFORMATION AND DELAYING AND LIMITING THE INSPECTION Wockhardt Ltd was recently audited by the FDA during the timeframe of March 18 – 22, 2013 at their Biotech Park, Aurangabad, India. During this audit the FDA documented that Wockhardt Ltd was found to have withheld truthful information, and delayed and limited the inspection. The delay … [Read more...]
FDA’s GUIDANCE FOR INDUSTRY PROVIDES CIRCUMSTANCES THAT CONSTITUTE DELAYING, DENYING, LIMITING OR REFUSING A DRUG INSPECTION
LEARN OF FDA's CURRENT THINKING REGARDING AUDITING ISSUES The FDA recently released a new DRAFT Guidance for Industry on July 12, 2013 that is entitled "Circumstances that Constitute Delaying, Denying, Limiting or Refusing a Drug Inspection". The Draft Guidance for Industry uses examples that illustrate the most common situations that the FDA has encountered and provides very … [Read more...]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...]
