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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Labor L+S AG - Close Out Letter 4/24/13

  

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

Public Health Service
Food and Drug Administration
 Office of Manufacturing and Product Quality
Division International Drug Quality
International Compliance Branch
10903 New Hampshire Avenue
Building #51, Room 4233
Silver Spring, MD 20993

TELEPHONE: (301) 796-3192
                 FAX: (301) 847-8742

 

April 24, 2013


Dr. Lothar Bomblies
Member of the Board
Labor L+S AG
Mangelsfeld 4
Bad Bocklet-Grossenbrach
Germany D-97708


Reference: FEI 3002807481


Dear Dr. Bomblies:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter: 320-12-07, December 15, 2011. Based on our evaluation, it appears that you have
addressed the violation(s) 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/

Christina Alemu-Cruickshank
Compliance Officer
Division of International Drug Quality