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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Human Biosciences, Inc. - Closeout Letter 8/12/13


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

Public Health Service
Food and Drug Administration
 Baltimore District Office
Central Region
6000 Metro Drive
Baltimore, MD 21201-2199
Telephone: (410) 779-5455
FAX: (410) 779-5705 


August 12, 2013

Dr. Manoj K. Jain, CEO
Human Biosciences, Inc.
940 Clopper Rd.
Gaithersburg, MD 20878

Dear Dr. Jain,

On July 19, 2013, The Food and Drug Administration completed an evaluation of your firm's corrective actions in response to our Warning Letter (#281637), dated May 10, 2012. 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.

CDR Rochelle B. Young, RPh, MSA
Compliance Officer, Baltimore District Office