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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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H & H Products Company 5/22/09


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

Public Health Service
Food and Drug Administration
  555 Winderley Pl., Ste. 200
Maitland, FL 32751





May 22,2009


Morris L. Hartley, President
H & H Products Company
6600 Magnolia Homes Road
Orlando, Florida 32810-4267

Dear Mr. Hartley:

We inspected your juice processing facility, located at the above address, on January 14, 15 and 20, 2009. We found that you have a serious violation of the juice Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 120 (21 CFR 120). In accordance with 21 CFR 120.9, failure of a processor of juice products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 120, renders the juice products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4). Accordingly, your juice concentrates are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, the juice HACCP regulation and the Juice HACCP Hazards and Controls Guidance through links in FDA's home page at www.fda.gov.

The significant deviation was as follows:

>You must include in your HACCP plan control measures that will consistently produce, at a minimum, a 5 log reduction, for a period at least as long as the shelf life of the product when stored under normal and moderate abuse conditions, in the pertinent microorganism, to comply with 21 CFR 120.24(a). However, your HACCP plan for juice concentrates fails to list measures that would bring about a 5-log reduction in the pertinent microorganism. This 5-log reduction and final product packaging must be accomplished in your facility through treatments applied directly to the juice to comply with 21 CFR 120.24(b) and (c).

For your information, we are also enclosing a copy of an FDA Guidance for Industry that may be helpful to your firm, entitled "Guidance on Bulk Transport of Juice Concentrates and Certain Shelf Stable Juices." This guidance is also available on FDA's website at http://www.cfsan.fda.gov/~dms/juicgui8.html.

This  letter may not list all the deviations at your facility. You are responsible for ensuring that your facility operates in compliance with the Act and all regulations. You also have a responsibility to use procedures to prevent further violations of the Act and all applicable

In addition, we received a letter from your firm dated January 26, 2009 in response to the form FDA 483 issued to you on January 20, 2009 at the conclusion of our most recent inspection. We have reviewed your response and find it to be inadequate because it does not adequately address your failure to perform a 5-log reduction on your juice concentrates.

Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things that you are doing to correct this deviation. You may wish to include in your response documentation such as your HACCP plan, copies of your Sanitation Standard Operating Procedure, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any
remaining deviations.

Please send your reply to the Food and Drug Administration, Attention: Brant M, Schroeder, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida, 32751. If you have any questions regarding any issue in this letter, please contact Mr. Schroeder at (407) 475-4763.






Emma R. Singleton

Director, Florida District



Enclosure: Guidance on Bulk Transport of Juice Concentrates and Certain Shelf Stable Juices


cc: Richard C. Matthes, Plant Manager