Today FDA posted its latest batch of Warning Letters. They can be accessed in Adobe PDF format by clicking on the link following each letter.
Pucheng Chia Tai Biochemistry Co., Ltd. Pucheng, Fujian Province,China (2/27/08). Inspected API facility 9/17-21/07. GMP deviations, adulterated: The firm has not adequately addressed whether the final batch production test records, and the in-process test records, contain true and accurate information. FDA says the firm’s response does not clarify which personnel actually perform the identification test for chlortetracycline hydrochloride and therefore leaves open the authenticity of the data appearing on prior and future final documents for this drug. The quality unit failed to assure that its organizational structure, procedures, processes, and activities are adequate to ensure that APIs will meet their intended specifications for quality and purity. FDCA 501(a)(2)(B) (CVM-08002)
True Renewal Provo, UT (1/6). Reviewed Web sites at www.truerenewal.com, www.healthwithmms.com, www.drjenine.com, and www.oxypowdercleanse.com. Unapproved new drugs, misbranded: Some of the claims on the Web sites that make the products drugs include: Hundreds of lives have been saved. Reports of overcoming incurable diseases are happening every day, etc. (Miracle Mineral Supplement, Dr Ohhira Essential Formulas Probiotics 12 Plus Original Formula, Graviola, Graviola Max, and Livatrex ); FDCA 502(f)(1), 505(a) (No Code)