Please also address in your response to this letter the following issues:Maybe you should write the FDA and tell them what you think about importing dangerous drugs from China?
During the inspection, the investigators were informed that your firm does not distribute heparin sodium directly to the U.S. and that the product manufactured was shipped to Shanghai. During an inspection conducted at a U.S. facility, we found purchase orders and information indicating that since 2005, heparin sodium manufactured at your facility was being shipped into the U.S. Please clarify whether you shipped drugs directly to the U.S. and provide a list of all lots of heparin sodium (intended for experimental or commercial use) shipped to the U.S. since your firm started to manufacture heparin sodium. Please also identify whether you shipped drugs that you understood were ordered by or ultimately destined for the U.S., even if you did not ship them directly to the U.S. yourself. Also include a list of any other customers to whom you have supplied heparin sodium or other substances intended for the U.S. market. Include the amounts shipped and dates of all shipments.
Please also explain the relationship between your firm and (b)(4). Please provide information regarding any lots of heparin sodium that were shipped by (b)(4) on your firm’s behalf, including lot numbers, dates of shipments and amounts.
In light of the above and the fact that your predecessor (Qingdao Kangyuan) was never inspected by FDA and apparently no longer manufactures heparin sodium, we expect you to address the reliability of any information generated regarding the manufacture, processing, testing, packaging, and labeling of heparin sodium shipped to the U.S. and used to support your DMF 22222.
One way you can do this is by employing a third party auditor to conduct a validity assessment of the information you have provided or intend to provide to support your DMF regarding the production of heparin sodium. Conducting such an audit could expedite the process of re-qualifying your facility.
The listed deficiencies are not to be considered an all inclusive list of deficiencies at your facility. FDA inspections are audits, which are not intended to address all deviations from CGMP or all violations which may exist at a firm. If you wish to ship your products to the U.S., you are responsible for ensuring compliance with all U.S. standards for CGMP and all other applicable U.S. laws and regulations.
Until FDA has confirmed corrections of the deficiencies and compliance with CGMP, this office may recommend withholding approval of any new applications listing your firm as the drug manufacturer. In addition, shipments of articles manufactured at Qingdao Jiulong Biopharmaceutical Co., Ltd located at Jiulong Indusrial Garden Jiaozhou, Qingdao, Shangdon Providence 266319, People’s Republic of China facility and shipped into the U.S. are subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C; Act [21 U.S.C. 381(a)(3)], in that, the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of Section 501(a)(2)(B) of the FD&C; Act [21 U.S.C. 351(a)(2)(B)].
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice. Please respond to this letter within 30 days of receipt. Please identify your response with FEI 3006745882. If you have any questions concerning this letter, you may contact Carmelo Rosa, Compliance Officer at the address and telephone numbers shown below.
U.S. Food & Drug Administration Center for Drug Evaluation and Research Division of Manufacturing and Product Quality International Compliance Team White Oak Building 5110903 New Hampshire Avenue Silver Spring, Maryland 20993 Tel: (301) 796-3667 Fax: (301) 301-847-8741
Sincerely,
/s/
Richard L. Friedman Director Division of Manufacturing and Product Quality Office of Compliance Center for Drug Evaluation and Research Office of Compliance
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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