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...]
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...]
INDIAN MANUFACTURING FACILITIES CONTINUE TO RECEIVE FDA REGULATORY ACTIONS
HOSPIRA'S IRUNGATTUKOTTAI FACILITY RECEIVES WARNING LETTER (052813) Recently Ranbaxy settled a $500 million lawsuit with the Dept. of Justice for selling improperly manufactured and tested drugs (see previous Blogs). More recently, Maharashtra-based Wockhardt received an Import ban (see previous Blogs to learn of what other Indian based … [Read more...]
APOTEX INC RECEIVES WARNING LETTER FOR MULTIPLE CANADIAN SITES (2/21/13)
FIRM FAILED TO ESTABLISH AND FOLLOW PROCEDURES DESIGNED TO PREVENT MICROBIOLOGICAL CONTAMINATION (21 CFR 211.113(b)) The FDA, during August and October 2012 inspected two Apotex, Inc. sites. This Blog only discusses the facilities located at 150 Signet Drive, Toronto, Canada. The U.S. Food and Drug Administration (FDA) identified significant … [Read more...]
MERCK KGaA RECEIVES WARNING LETTER (12/15/11)
FDA INCLUDES THREE EUROPEAN FACILITIES TO INCLUDE MERCK SERONO S.A., AUBONNE, SWITZERLAND WITH MEDIA FILL ISSUES The FDA released on Wednesday, February 17, 2012 a Warning Letter that was sent to Merck KGaA on December 15, 2011. Within the Warning Letter the FDA advised Merck KGaA management of deficiencies at three separate facilities, two in Switzerland and one in Rome, … [Read more...]
