COMMENT:  Rarely does one observe such a flagrant number of mislabeled Active Pharmaceutical Ingredients (API) noted within a Warning Letter (Click Here). In this Warning Letter, two of six samples of L-Citrulline repackaged for distribution to Pharmacies for use in compounding were tested by the FDA found to not be as labeled. The firm … [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...]
