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Chromsystems Instruments & Chemicals GmbH

Chromsystems Instruments & Chemicals GmbH

United States

Issuing Office:

United States


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

Public Health Service
Food and Drug Administration
 10903 New Hampshire Avenue
Silver Spring, MD 20993 

NOV 17, 2016

Mr. Michael Meier, Managing Director
Chromsystems Instruments & Chemicals GmbH
Am Haag 12,
Grafelfing, DE 82166


Dear Mr. Meier:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter #432126 August 8, 2014. 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.


James L. Woods, W066-5688
Deputy Director
Patient Safety and Product Quality
Office of In Vitro Diagnostics and
Radiological Health
10903 New Hampshire Avenue
Silver Spring, MD20993

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