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U.S. Department of Health and Human Services

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Bryant Ranch Prepack - Response 4/16/10

12623 Sherman Way Unit A
North Hollywood, CA 91605
Voice: (818) 764-7225 Fax: (877) 277-7552
Director of Sales : Fred Ganjian RPH MS Extension 1
Sales Department Email: brpfred@bryantranchprepack.com
Director of Pharmacy: Kambiz Monem, Pharm D. Extension 2
President: Robert Mernick, Extension 3
Company Email: brpprepack@bryantranchprepack.com

4/16/2010 11:46:00 AM

Daniel Cline, Acting Director
Los Angeles District Domestic Compliance Branch
19710 Fairchild
Irvine, CA 92612-2506

Re: FDA Warning Letter Dated April 8, 2010, No. W/L 13-10

Dear Mr. Cline:

On behalf of my firm, please be assured that we take the FDA’s concern, as expressed in the above reference Warning Letter, very seriously and we wish to remediate the situation in a timely manner. To assist in this endeavor, we have engaged the consulting services of (b)(4) resume can be found attached to this letter. (b)(4) will be assisting us in formulating a comprehensive response to the above referenced Warning Letter, and in this regard, has our permission to communicate with you and/or any other FDA staff person you designate.

As a first step in response to your warning letter we have ceased to package or distribute any and all products which are made for (b)(4)  including the list of products contained in the warning letter. We have quarantined the current products in inventory in preparation of returning them to the offices and warehouse of (b)(4). It is our intention to remove and retain all of our packaged generics from the (b)(4) before returning them. We are doing this at a significant financial burden in order to comply with the concerns of the FDA, and to protect the health of the citizens of the United States.

Regarding the other concerns as expressed in the Warning Letter, we will be addressing these as soon as possible in a subsequent letter.

Sincerely,

Robert Mernick
President, Bryant Ranch PrePack

Cc: (b)(4)

Acting Branch Chief
Food and Drug Branch California Dept. of Public Health
1500 Capitol Avenue – MS 7602
PO Box 997413
Sacramento, CA 95899-7413