Inspections, Compliance, Enforcement, and Criminal Investigations

Beijing Shunxin Meihua Bio-technical Co., Ltd. 9/29/14

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Silver Spring, MD  20993 

 

Warning Letter

 
CERTIFIED MAIL                                                                        
RETURN RECEIPT REQUESTED
 
September 29, 2014

Mr. Qing Long Ge
General Manager
Beijing Shunxin Meihua Bio-technical Co., Ltd
Bei Fa Xin Duan
No. 7 Fuqian Road
Daxingqu, Shunyi District
Beijing  101300
China
 
Dear Mr. Ge:
 
On February 19, 2014, the U.S. Food and Drug Administration (FDA), arrived at your drug manufacturing facility, Beijing Shunxin Meihua Bio-technical Co., Ltd., located at Bei Fa Xin Duan, No. 7 Fuqian Road, Daxingqu, Shunyi District, Beijing, China, to conduct an inspection.  The FDA investigators documented that your firm limited and/or refused an FDA inspection.  Under the Food and Drug Administration Safety and Innovation Act (FDASIA), Section 707, your drugs are adulterated within the meaning of Section 501(j) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 351(j), in that they have been manufactured, processed, packed, or held in an establishment where the owner or operator has limited inspection and/or refused inspection.
 
Your firm limited an inspection and/or refused to permit the FDA inspection as follows:  
 
1.   Your site produces crude heparin for purification into finished API. On February 19, 2014, FDA investigators explained the purpose of the inspection to you as the most responsible official at Beijing Shunxin Meihua Bio-technical Co., Ltd, (hereafter Shunxin).  You barred the investigators access to the production area and other parts of the manufacturing facility. In several instances, the investigators requested to inspect the facility, but were repeatedly denied access to the production area.  Your firm also limited FDA access to certain requested records. For example, the FDA investigators requested batch production records for review, but were refused access to these records repeatedly.
 
Furthermore, during the review of a list of your suppliers, one of the few documents you did provide, we noted that you are supplied by (b)(4), which research indicates has the same physical address as, and is thus an alias of, the (b)(4), a firm that is currently on FDA Import Alert 55-03, “Detention Without Physical Examination of Different Forms of Heparin and Heparin-Related Products.”  This Import Alert can be found on the FDA public website:  
 
 
Import Alert 55-03 includes firms for which there is information indicating that their heparin and/or heparin-related products appear to be adulterated.  One basis for detention without physical examination under Import Alert 55-03 is that the firm’s quality system is inadequate for the prevention of contamination (including oversulfated chondroitin sulfate (OSCS))or otherwise does not conform with CGMP.  If your firm is being directly or indirectly supplied by establishments that are associated with historical OSCS contamination or that otherwise lack adequate CGMP, your firm could be manufacturing heparin and heparin-related drugs that could be subject to import alert.  FDA recommends that you ensure that you properly evaluate and qualify all your suppliers (e.g., suppliers of crude heparin or heparin API), as required by CGMP, and change the source of your supply, where appropriate.  Consequently, your use of this supplier on Import Alert 55-03 led to the appearance of adulteration of your heparin drugs.
 
We also note that FDA test results confirmed the presence of ruminant DNA in one of two samples of porcine crude heparin produced at your site and collected at the facility of one of your customers in China.  The sample containing the ruminant DNA came from your crude heparin batch BB120425. The FDA test method that revealed these positive results is available at the following website:
 
 
For further reference regarding ruminant DNA in heparin, please also see the guidance “Guidance for Industry: Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality” that can be found at the following website:
 
 
Your firm was placed on Import Alert 55-03, Import Alert 66-40, and Import Alert 99-32 on July 22, 2014.
 
The violation cited in this letter is not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of the violation identified above and for preventing their recurrence and the occurrence of other violations.
 
Until FDA is permitted to inspect your facility and confirms compliance with CGMP, this office may recommend withholding approval of any new applications or supplements listing your firm as a drug manufacturer. In addition, shipments of articles manufactured at Beijing Shunxin Meihua Bio-technical Co., Ltd, Beijing, China into the United States are subject to refusal of admission pursuant to Section 801(a)(3) of the Act, 21 U.S.C. 381(a)(3). 
 
Please submit any written response within fifteen working days of receipt of this letter.  
 
Please identify your response with FEI # 3010657600.
 
Please send your reply to:
Mary D. Davis-López
Compliance Officer
U.S. Food and Drug Administration
Center for Drug Evaluation and Research
Office of Manufacturing and Product Quality
Division of International Drug Quality
White Oak, Building 51
10903 New Hampshire Ave
Silver Spring, MD 20993
Tel: (301) 796-8859
Fax: (301) 847-8741
 
 
Sincerely,
/S/                   
Thomas J. Cosgrove, J.D.
Acting Director
Office of Manufacturing and Product Quality
Office of Compliance
Center for Drug Evaluation and Research

Page Last Updated: 10/14/2014
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