Inspections, Compliance, Enforcement, and Criminal Investigations

Fenwal Inc 10/14/16

  

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

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

 

October 14, 2016
 
WARNING LETTER
 
CBER-17-01
 
VIA FACSIMILE AND UPS
 
Barry Hicks
Manager Regulatory Affairs
Fenwal, Inc. - A Fresenius Kabi Company
Three Corporate Drive, Building 3
Lake Zurich, IL 60047
 
Re:   BN080041
         InterSol® (Platelet Additive Solution 3)
 
 
Dear Mr. Hicks:
 
The Advertising and Promotional Labeling Branch (APLB) of the Office of Compliance and Biologics Quality in the Food and Drug Administration's Center for Biologics Evaluation and Research (CBER), in consultation with CBER’s Division of Hematology Research and Review, has reviewed your Presentation slides to introduce InterSol Solution to blood collection facility staff  (Material ID #2871), submitted by Fenwal, Inc.- A Fresenius Kabi Company under cover of Form FDA-2253 for InterSol® (Platelet Additive Solution 3).
 
The promotional material is misleading because it presents efficacy claims for Intersol, but omits all risk information for InterSol. Therefore, your material misbrands InterSol under Sections 502(f)(2)and  201(n) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. §352(f)(2) and §321(n), and implementing regulations.  These violations are concerning from a public health perspective because they create a misleading impression about the safety and effectiveness of InterSol.
 
Moreover, we are concerned by your continued violative promotion of your product. Fenwal, Inc. was cited for similar violations in a Warning Letter dated June 1, 2012.
 
Background
 
According to the FDA-approved prescribing information (PI), InterSol is an isotonic solution designed to replace a portion of the plasma used in the storage of AMICUS™-derived leukocytes apheresis platelets under standard blood banking conditions. There is no direct therapeutic effect to be expected from the formulation. The solution should never be infused into a patient.
 
The Warnings and Precautions section of the PI states:
  • InterSol solution is NOT FOR DIRECT INTRAVENOUS INFUSION.
  • Do not use if particulate matter is present or if the solution is cloudy.
  • Do not use if the container is damaged, leaking or if there is any visible sign of deterioration.
  • Do not vent.
  • Do not reuse. Discard unused or partially used InterSol solution.
  • Protect from sharp objects.
  • Verify that the InterSol solution has been securely attached to the PAS Connector line to avoid disconnection and leaks. 
Omission of Risk Information
 
Promotional materials are misleading if they fail to reveal facts that are material in light of the representations made by the materials or with respect to consequences that may result from the use of the drug as recommended or suggested by the materials.
 
The submitted slide presentation fails to provide facts material to the consequences that may result from the use of InterSol, including warnings and precautions, as well as the risk due to direct infusion. This omission of risk information results in your product being misbranded within the meaning of Sections 201(n) and 502(f)(2) of the Act, 21 U.S.C. 321(n) and 352(f)(2).
 
Conclusion and Requested Actions
 
For the reasons discussed above, your promotional material misbrands InterSol under Sections 201(n) and 502(f)(2) of the Act, 21 U.S.C. 321(n) and 352(f)(2). We request that you immediately cease the dissemination of violative promotional materials described above and the same or similar materials for InterSol.
 
Please submit a written response to this letter within ten (10) business days of its receipt, stating whether you intend to comply with this request, listing all promotional materials in use for InterSol that contain violations such as those described above, and explaining your plan for discontinuing use of such violative materials.
 
Additionally, since we have cited you previously for similar violations, we request a response in writing, indicating what policies and procedures you intend to adopt to ensure that your prescription drug promotional activities comply with the Act and its implementing regulations, and an explanation of why/how you expect these policies and procedures to succeed. 
 
Please direct your response to me at the Food and Drug Administration, Center for Biologics Evaluation and Research, Office of Compliance and Biologics Quality, HFM-600, 10903 New Hampshire Ave Silver Spring, Maryland 20993-0002. In all future correspondence regarding this matter, please refer to the NDA number.
 
We remind you that only written communications are considered official responses. If you choose to revise your promotional materials, we are willing to assist you with your revised materials by commenting on your revisions before you use them in promotion.
 
Failure to correct the violations discussed above may result in FDA regulatory action, including seizure or injunction, without further notice.
 
Sincerely,
/S/
Mary A. Malarkey
Director
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research
 

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