FIRM FAILS TO ASSURE ADEQUATE USE OF SPORICIDAL AGENTS AND CLEANING SUPPLIES Jubilant HollisterStier, Spokane, WA was audited by the FDA between April 15 and May 10, 2013. The FDA reviewed the firm’s response from May 30 and noted that sufficient corrections actions were lacking. The FDA also received additional correspondence dated July 12 and August 15, but believed that a … [Read more...]
JUBILANT HOLLISTERSTIER, LLC RECEIVES WARNING LETTER (11/27/13)
FIRM FAILS TO PERFORM MEDIA FILL PROCESS SIMULATIONS FOLLOWING MAJOR RENOVATION Jubilant HollisterStier, Spokane, WA was audited by the FDA between April 15 and May 10, 2013. The FDA reviewed the firm’s response from May 30 and noted that sufficient corrections actions were lacking. The FDA also received additional correspondence … [Read more...]
Wockhardt’s Walui and Chikalthana Facilities, Maharasthtra Receive Warning Letter (11/25/13)
Data Manipulation Continues to be a Major Issue After a somewhat quiet month, CDER is again active in India. Their current concern is with a Company that should be familiar to each of us. And the issues in many cases are similar to those found within a Warning Letter issued in July of this year. Alexander Gaffney, RAPS Editor, has put together an excellent summary of this … [Read more...]
PHARMACEUTICAL FIRM RECALLS NASAL SPRAY FOR POTENTIAL MICROBIAL CONTAMINATION (10/02/13)
NEPHRON PHARMACEUTICALS APPLAUDED FOR PROACTIVE STANCE Nephron Pharmaceuticals Corporation, Orlando, FL (NPC) recalled 689,568 cartons (ten lots) of Albuterol Sulfate Inhalation Solution for oral inhalation. The recall, which was initiated by the firm and was voluntary, was caused by a “Lack of Assurance of Sterility: … [Read more...]
NEW DRUG MICROBIOLOGY STAFF MEMBER PRESENTS INFORMATION ON ON-GOING PILOT PROGRAM
PROGRAM INCLUDES THE REVIEW OF NON-STERILE PRODUCTS John W. Metcalfe, Ph.D., of the New Drug Microbiology Staff at CDER gave an excellent, informative presentation on “Regulatory Review Perspectives for Non-Sterile Drug Products” at the PDA Global Microbiology Conference on Monday, October 21, 2013 in Bethesda, MD. This presentation presented information on a Pilot Program … [Read more...]
