Inspections, Compliance, Enforcement, and Criminal Investigations
R & Z Ventures dba Kennesaw Fruit & Juice 7/1/09
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|555 Winderley Pl., Ste. 200|
Maitland, Fl 32751
RETURN RECEIPT REQUESTED
Leonard Roseberg, President
R & Z Ventures
dba Kennesaw Fruit & Juice
1300 SW 1sl Court
Pompano, Florida 33069-3204
Dear Mr. Roseberg:
We inspected your firm, located at the above address, on February 23-27, 2009 and found that you have serious deviations from the Juice Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 120). In accordance with 21 CFR 120.9, these deviations, which were previously brought to your attention, cause your 100% juice products [orange, tangerine and grapefruit] to be in violation of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 342(a)(4)]. You can find the Act and the juice HACCP regulation through links in FDA's home page at www.fda.gov.
The deviations were as follows:
You must take a corrective action when a deviation from a critical limit occurs, to comply with 21 CFR 120.10. However, your firm did not take a corrective action to control pathogens (salmonella and E. coli) when your process for Fresh Citrus Juice deviated from your critical limit at the "Cleaning and Sanitizing Fruit" (CCP #3 and #6) critical control points. The critical limit in your HACCP plan at these CCPs requires the Citric Acid Activator level to range from 140-160 ppm. However,
o On February 25, 2009 you performed testing of citric acid chemical levels at CCPs #3 and #6. The test found the levels to be 120 ppm; this value was recorded on the monitoring form, "Production Chemical Level Verification." No corrective actions were performed.
o Review of monitoring records for the period from September 2008 to February 2009 revealed eight citric acid level test results of 120 ppm (February 2, 4, 5, and 13, 2009). No corrective actions were performed.
Your letter dated April 1, 2009 states that you made changes to your process (i.e.. you changed your critical limits at these CCPs) without revalidating your HACCP plan. We are particularly concerned with this observation because your firm has made changes to your fruit processing procedure in the past without revalidating your HACCP plan as required by 21 CFR 120.11 (b). This was discussed with you during FDA's January 2006 inspection of your facility. Your letter dated April 1, 2009 does not adequately address this deviation because it does not include documentation demonstrating the corrections you describe.
You must monitor conditions and practices during processing with sufficient frequency to ensure conformance with current good manufacturing practice regulations, to comply with 21 CFR 120.6(b). However, your firm did not monitor the protection of food, food packaging material, and food contact surfaces from adulteration with sufficient frequency, as evidenced by mold on the underside of the white plastic awning that bottles were conveyed through prior to filling. Mold was also observed on the ceiling in the bottling room directly above the cap hopper and fill station. We note that management promised to correct this deviation at the end of the inspection, however, the deviation is not discussed in your April 1, 2009 response letter.
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 regulations.
In addition, we acknowledge receipt of a letter from your firm dated April 1, 2009. As explained above, your response did not adequately address the deviations listed in this letter.
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 these deviations. 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.
We also have the following comment regarding your firm's HACCP plan for Fresh Citrus Juice. Your HACCP plan requires "A supplier guarantee specifying that the shipments include only picked fruit" at the Receiving Critical Control Point (CCP #1) and states that this requirement will be monitored annually. FDA recommends that you obtain a written guarantee from your supplier for each fruit shipment stating that the shipment contains only tree-picked fruit. We note that you stated in your April 1, 2009 letter that your firm is in the process of implementing such a procedure.
Please send your reply to the Food and Drug Administration, Attention: Brant 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