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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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PhotoMedex, Inc. - Close Out Letter 3/19/13

  

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

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

 

 

CERTIFIED MAIL
RETURN RECEIPT REQUESTED


March 19, 2013


Dennis M. McGrath
President and CFO
ProCyte Corporation,
a subsidiary of PhotoMedex, Inc.
147 Keystone Drive
Montgomeryville, PA 18936


Dear Mr. McGrath:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter 12-PHI-07, issued January 26, 2012. 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: Alyssa Schwartz, RA/QA Director

 

 

 

  

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

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

 

March 19, 2013

 

Dennis M. McGrath
President and CFO
ProCyte Corporation,
a subsidiary of PhotoMedex, Inc.
147 Keystone Drive
Montgomeryville, PA 18936


Dear Mr. McGrath:

Enclosed please find a close out letter for the Warning Letter issued to your firm on January 26, 2012. This letter is being issued in response to our inspection of your facility on November 19-27, 2012, and your firm's subsequent responses, dated December 11, 2012 and December 31, 2012.

We acknowledge your firm has initiated corrections, though our review finds that your corrective actions in general have not been timely. You are advised that the attached letter does not negate your firm's commitments outlined in your written responses and made verbally to our investigator during the inspection, including commitments made for submission of corrective action documentation to the Agency and correction of your labeling as discussed during the inspection. Additionally, your firm's labeling has been submitted to CDRH for review; you may be notified under separate cover if concerns are identified in
addition to those discussed in the Warning Letter and during our recent inspection.

If you have any questions pertaining to the content of this letter or the attached letter, please contact me at 215-717-3078 or Kristina.Donohue@fda.hhs.gov.


Sincerely,

/S/

Kristina Donohue
Compliance Officer
Philadelphia District Office


cc: Alyssa Schwartz, RA/QA Director