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RESPONSE LETTER

Leiter's Compounding


Company:
Leiter's Compounding

April 21, 2015


Mr. Lawton Lum
Director, Compliance Branch
US Food and Drug Administration
San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502


Re: Warning Letter
Leiter's Compounding Pharmacy
1700 Park Ave #30
San Jose, CA 95126



Dear Director Lum:

Please accept this written response to the Warning Letter Issued on April 14, 2015.

Leiter's Cambrian Park Drugs, dba Leiter's Compounding Pharmacy ceased compounding on 7/14/2014. Additionally, Leiter's Compounding Pharmacy ceased retail dispensing and closed its doors as of 3/30/2015. The DEA certificate and the Pharmacy permits have been surrendered to the appropriate agency on 3/31/2015. As of 3/31/15, there is no pharmacy at this location; and therefore, no compounding is being done at that facility now or in the future.

Finally, please note, we do not compound domperidone; our last lot was compounded 7/14/2014 and expired 1/10/2015. All sterile and non sterile items compounded out of our facility on our final day of production are past their beyond use dating. The latest date of expiration would be the 1/10/2015.


Sincerely,

/S/
__________________________________________________________________________________________
Charles W Leiter PharmD
Leiter's Cambrian Park Drugs
1700 Park Ave #30
San Jose, CA 95126
408 291-2431