Inspections, Compliance, Enforcement, and Criminal Investigations

Shandong Vianor Biotech Co., Ltd. 9/12/17

 

  

Black HHS-Blue FDA Logo

 

 

 
10903 New Hampshire Avenue
Silver Spring, MD 20993 

 

Via UPS                                                                                 Warning Letter 320-17-51
Return Receipt Requested
 
 
September 12, 2017
           
Ms. Cui Shanshan
General Manager
Shandong Vianor Biotech Co., Ltd.
Science Park, West End Naning Rd., Nanfang, Lanshan District
Linyi Shandong 276000
China
 
Dear Ms. Cui Shanshan:
 
The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Shandong Vianor Biotech Company at Science Park, West End Naning Road, Nanfang, Lanshan District, Linyi Shandong, from May 8 to 10, 2017.
 
This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See 21 CFR, parts 210 and 211.
 
Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).
 
We reviewed your May 25, 2017, response in detail.
 
Your response is inadequate. Although you committed to addressing the observations we identified, your response lacks detail. You also did not include a retrospective review of the effects of CGMP deficiencies on the quality of your products already distributed to the United States.
 
During our inspection, our investigator observed specific violations 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)).
 
Your management acknowledged falsifying analytical test results that were used to support your release of (b)(4)  (lot (b)(4)) to the United States.
 
2.    Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products (21 CFR 211.22(a)).
 
Your laboratory analysis revealed that (b)(4) lot (b)(4) was subpotent. However, the certificate of analysis (CoA) provided showed that it was within specification. When questioned about why the CoA reported passing results even though the batch actually failed, your quality unit manager stated, “I made a mistake.”
 
3.    Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements (21 CFR 211.67(a)).
 
Our investigator observed what appeared to be rusted and corroded screws, (b)(4) fluid and debris, and metallic mesh material on the product contact surfaces of (b)(4) located in your facility.
 
Access to information during inspection
 
During the inspection, you initially barred our investigator from accessing a room identified as a laboratory. You eventually allowed the investigator to inspect the laboratory, but he found that it contained no equipment. You then stated that the laboratory was offsite at a (b)(4) residence and that you could not give our investigator access as it was not a convenient time.
 
When an owner, operator, or agent delays, denies, limits, or refuses an inspection, the drugs manufactured, processed, packed, or held in the facility may be deemed adulterated under section 501(j) of the FD&C Act. See FDA’s guidance document, Circumstances that Constitute Delaying, Denying, Limiting or Refusing a Drug Inspection, at https://www.fda.gov/downloads/regulatoryinformation/guidances/ucm360484.pdf.
 
Conclusion
 
Violations cited in this letter are not intended as an all-inclusive list. You are responsible for investigating these violations, for determining the causes, for preventing their recurrence, and for preventing other violations.
                                
FDA placed your firm on Import Alert 66-40 on August 22, 2017.
 
Until you correct all violations completely and we confirm your compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as a drug manufacturer.
 
Failure to correct these violations may also result in FDA continuing to refuse admission of articles manufactured at Shandong Vianor Biotech Co., Ltd. at Science Park, West End Naning Rd., Nanfang, Lanshan District, Linyi Shandong, into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Under the same authority, articles may be subject to refusal of admission, 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).
 
After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done since our inspection to correct your violations and to prevent their recurrence. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.
 
Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov or mail your reply to:
 
Ms. Rokhsana Jazi
Compliance Officer
U.S. Food and Drug Administration
White Oak Building 51, Room 4359
10903 New Hampshire Avenue
Silver Spring, MD 20993
USA
 
Please identify your response with FEI 3011717652.
 
Sincerely,
/S/
Thomas J. Cosgrove
Director
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research
 
 
cc:     (b)(4)         

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