2015年FDA警告信（生产amp;产品质量）.doc

2013年FDA警告信（生产产品质量） Wockhardt Limited 11/25/13 ? ? Department of Health and Human Services Public Health ServiceFood and Drug Administration ? Silver Spring, MD? 20993? ? Warning Letter ? WL:?320-14-01 CERTIFIED MAIL???????????????????????????????????????????????????????????????????????? RETURN RECEIPT REQUESTED ? November 25, 2013 Dr. Habil Khorakiwala Founder, Chairman Group CEO Wockhardt Limited Bandra Kurla Complex, Bandra (East) Mumbai, Maharashtra 400 051, India ? Dear Dr. Khorakiwala: ? During our July 22-31, 2013 simultaneous inspections of your pharmaceutical manufacturing facilities, Wockhardt Limited (FEI 3002808503) located at L-1, M.I.D.C. Area, Chikalthana, Aurangabad, Maharashtra, India, and Wockhardt Limited (FEI 3004540156) located at B-15/2, M.I.D.C. Area, Waluj, Aurangabad, Maharashtra, India, investigators from the U.S. Food and Drug Administration (FDA) identified significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, Title 21, Code of Federal Regulations, Parts 210 and 211.?These violations cause your drug products to be adulterated within the meaning of Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 351(a)(2)(B), in that the methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, CGMP.? ? We have conducted a detailed review of your firm’s responses and note that they lack sufficient corrective actions.? ? We also acknowledge receipt of your firms additional correspondence dated October 2, 2013.?? Our investigators observed specific violations during the inspection, including, but not limited to, the following: ? 1.? Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards (21 CFR 211.194(a)).? ? For exa