Inspections, Compliance, Enforcement, and Criminal Investigations
Juice Company, LLC 10-Jul-07
Department of Health and Human Services
Public Health Service
Food and Drug Administration
RETURN RECEIPT REQUESTED
July 10, 2007
Marc F.T. Craen, Chief Operating Officer
Juice Company, LLC
dba Lambeth Groves Juice Company
505 66th Avenue S.W.
Vero Beach, Florida 32968
Dear Mr. Craen:
We inspected your firm, located at the above address on February 21, 22, 28 and March 2, 2007. We found that you have a serious deviation from the Juice HACCP regulation (21 CFR 120). These deviations cause your unpasteurized orange juice and grapefruit juice to be adulterated pursuant to 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 regulations through links in FDA's homepage at http://www.fda.gov.
The deviation was as follows:
1. You must perform the appropriate follow-up activities when two samples in a series of seven tests are positive for E. coli, to comply with 21 CFR 120.25(e). However, when your. firm found two fresh squeezed orange juice samples, between November 10th and November 12th, 2006, in a series of seven that were positive for E. coli, you failed to take an appropriate action. Specifically, you failed to validate your HACCP plan in relation to your 5-log reduction standard, when you found two orange juice samples in a series of seven positive for E. coli [21 CFR 120.25(e)(2)(ii)]
We received letters from you dated March 19, 2007 and April 12, 2007 in response to the observations made during our February/March 2007 inspection of your facility. Your correspondence was in response to the Form FDA 483 issued to you on March 2, 2007, at the conclusion of that inspection. We have reviewed your response and find it to be inadequate at this time, because no supporting evidence, such as new validation studies or pictures displaying corrections, were provided substantiating the corrections.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your products and/or enjoin your firm from, operating.
Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these deviations. You may wish to include in your response documentation such as amended juice HACCP plans, revised forms, or other useful information that would assist us in evaluating your corrections. If you are unable to complete all of the corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining deviations.
This letter may not list all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the Juice HACCP Regulations, (21 CFR 120). You also have a responsibility to use procedures to prevent further violations of the U.S. Federal Food, Drug, and Cosmetic Act and all applicable regulations.
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.
Florida District Office