White & Blue Lion, Inc, City of Industry, CA recently recalled all lots of tattoo inks and tattoo needles due to pathogenic bacterial contamination. The recall indicated that the “use of these products may cause bacterial infection and can lead to sepsis, a potentially life-threatening complication of an infection. The recall includes all tattoo ink, tattoo needles, … [Read more...]
MARCK BIOSCIENCES LTD., KHEDA, INDIA RECEIVES WARNING LETTER (7/8/14)
ISSUES INCLUDE MOLD GROWTH AT STERILE MANUFACTURING ENTRY AND DEAD AND DECAYING FROGS NEAR THE PRODUCT EXIT DOCK Between October 29 and November 1, 2013, the FDA inspected Marck Biosciences Ltd., Kheda, India. As a consequence of this audit, the FDA issued six extensive Observations. This Blog only reviews Observation 5 (a) and 5 (b). “Your firm failed to maintain the … [Read more...]
ZHEJIANG JIUZHOU PHARMACEUTICAL CO. RECEIVES IMPORT ALERT (3/18/14)
FDA PROVIDES NO RATIONALE FOR ALERT After the Warning Letter for Zhejiang Jiuzhou Pharmaceutical Co. was published in a recent Blog (8/20/14), several of my colleagues sent me comments regarding this Chinese Active Pharmaceutical Ingredient (API) source. They were particularly intrigued by the Blog because one had observed an Import Alert that was issued by the FDA on March … [Read more...]
ZHEJIANG JIUZHOU PHARMACEUTICAL CO., LTD. (CHINA) RECEIVES WARNING LETTER (7/09/14)
APIs WERE MISBRANDED Zhejiang Jiuzhou Pharmaceutical Co., Ltd. (China) was inspected from October 21-24, 2013 at their active pharmaceutical ingredient manufacturing facility. Deviations from CGMP were noted in the manufacture of the API. “Failure to implement an effective system of managing quality and failure to transfer all quality or … [Read more...]
TRIFARMA S.p.A. (ITALY) RECEIVES WARNING LETTER (070714)
LETTER IS SIMILAR TO ONE RECEIVED BY CERIANO LAGHETTO PLANT (11/13) The FDA inspected the Trifarma S.p.A. pharmaceutical manufacturing facility, located at Via Pavese 2, Rozzano, Italy from January 27 – 29, 2014. They identified significant deviations from current good manufacturing practice (CGMP) for the manufacture of active pharmaceutical … [Read more...]
