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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Crothall Healthcare Inc - Close Out Letter 7/29/11

  

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

Public Health Service
Food and Drug Administration
 

New Orleans District
404 BNA Drive
Building 200 – Suite 500
Nashville, TN 37217
Telephone: (615) 366-7801
FAX: (615) 366-7802
 

July 29, 2011


Robert H. Ketteh, President/CEO
Crothall Healthcare, Inc.
955 Chesterbrook Boulevard
Wayne, Pennsylvania 19087


Dear Mr. Ketteh:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 2010-NOL-06, dated December 29, 2009. Based on our evaluation, it appears 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/

Patricia K. Schafer
Compliance Branch Director
New Orleans District

cc: Paul J. Hickey, General Manager
Steripac, Inc.
606 32nd Street South
Birmingham, Alabama 35283