• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

  • Print
  • Share
  • E-mail

Animas Corporation - Close Out Letter 5/22/13

  

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

Public Health Service
Food and Drug Administration
 US Customhouse Room 900
200 Chestnut Street
Philadelphia PA 19106

 

May 22, 2013


Kenneth J. Tompkins
General Manager
Animas Corporation
200 Lawrence Drive
West Chester, Pennsylvania 19380-3428


Dear Mr. Tompkins:

Enclosed please find a close out letter for the Warning Letter issued to your firm on December 27, 2011.

We acknowledge your firm has initiated corrections, though our follow up inspection, conducted March 25 - April 12, 2013, found that further corrections are needed regarding Medical Device Reporting, CAPA, and both process and design validation. You are advised that the attached letter does not negate your firm's commitments made verbally to our investigators during the inspection, including commitments made for submission of corrective action documentation to the Agency, nor does it negate your responsibility to assure continued compliance with applicable federal regulations.

If you have any questions pertaining to the content of this letter or the attached letter, please contact Steven Carter, Philadelphia District Compliance Branch Director, at 215-717-3071 or Steven.Carter@fda.hhs.gov.


Sincerely,

/S/

Kristina Donohue
Compliance Officer
Philadelphia District Office


cc: Jon Mulberg
      Director, WW Quality Systems and Compliance


 

  

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

Public Health Service
Food and Drug Administration
 US Customhouse Room 900
200 Chestnut Street
Philadelphia PA 19106

 

CERTIFIED MAIL
RETURN RECEIPT REQUESTED


May 22, 2013


Kenneth J. Tompkins
General Manager
Animas Corporation
200 Lawrence Drive
West Chester, Pennsylvania 19380-3428


Dear Mr. Tompkins:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter 12-PHI-04, issued December 27, 2011. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.


Sincerely,

/S/

Steven L. Carter
Director, Compliance Branch
Philadelphia District Office

cc: Jon Mulberg
      Director, WW Quality Systems and Compliance