WARNING LETTER WL NO. 320-09-02In our next blog, we will continue with the warnings given to Qingdao with respect to its failure to conduct regular product quality reviews.
April 14, 2009
VIA FEDERAL EXPRESS
Ms. Wang Weiru President Qingdao Jiulong Biopharmaceuticals Co. Ltd. Jiulong Industrial Garden, Jiaoshou City Qingdao, People’s Republic of China (PRC) 266319
Dear Ms. Weiru:
This is regarding an inspection of your pharmaceutical manufacturing facility, Qingdao Jiulong Biopharmaceutical Co., Ltd. (QJBC) located at Jiulong Industrial Garden Jiaoz, Qingdao, Shangdon Providence 266319, People’s Republic of China, conducted by Investigator Carl Lee and Compliance Officer Zi-Qiang Gu, Ph.D., during the period of July 28 to August 1, 2008. The inspection and other information revealed significant deviations from U.S. current good manufacturing practices (CGMP) requirements in the manufacture of drugs.
Deviations were listed on an Inspectional Observations Form (FDA-483) issued to you at the close of the inspection. These and other CGMP deviations cause your heparin sodium to be adulterated within the meaning of Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the FD&C; Act) [21 U.S.C. 351(a)(2)(B)]. Section 501(a)(2)(B) of the Act requires that all drugs, as defined in the Act, be manufactured, processed, packed, and held according to CGMP.
We have reviewed your August 13, 2008 written response to the FDA-483 observations and subsequent response of November 7, 2008 to our Request for Additional Information Letter of September 29, 2008. We note that you assert that some corrections have been completed or will soon be implemented. However, your response does not adequately address some of the deficiencies. Our review of the information revealed the following CGMP violations:
1. Your firm’s quality unit fails to have the appropriate system and procedures to provide confidence that the drugs manufactured at your facility meet the intended specifications for identity, strength, quality and purity.
In April 2008, FDA learned that 19 lots of heparin sodium were contaminated with Over-Sulfated Chondroitin Sulfate (OSCS), and these lots were later determined to have been manufactured at your facility. Although this heparin sodium did not ultimately reach U.S. patients, your firm has not demonstrated that it has conducted an investigation of these contaminated lots, identified the source of this contamination, and taken appropriate corrective actions to ensure the quality of heparin sodium produced at this site. There is no assurance that your quality unit has systems in place to prevent manufacture and distribution of heparin sodium that has been contaminated with OSCS or other hazardous contaminants. These lots were supplied to Shanghai No. 1 Biochemical Pharmaceutical Co., Ltd. (Shanghai) over an extended period, spanning 2007 and 2008, for distribution under their name.
We are concerned that your firm lacked adequate systems to ensure the safety of raw materials used in your manufacturing, particularly to prevent the substitution of an unsafe substance (OSCS) in place of heparin sodium. It is essential that strict controls over your suppliers be established to prevent any such supply chain breach.
Your firm also failed to ensure that manufacturing and testing procedures apparently transferred to your facility provided for acceptable drug identity, strength, quality, and purity. It is critical for a firm to assess the impact of a change in manufacturing facility, including determining how production and control practices and conditions at the new facility may affect the identity, strength, quality, and purity of a drug.
During the August 2008 inspection, our investigators learned that your current manufacturing process for Heparin Sodium USP was apparently transferred in 2005 from Qingdao Kangyuan, which you assert is a related business entity, to your site and that Qingdao Kangyuan no longer manufactures heparin sodium. However, no information regarding the procedures, protocols and reports related to this technology transfer were available for review. Only estimated dates of when Qingdao Kangyuan ceased manufacturing heparin sodium and when your firm initiated production were provided.
Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.
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