Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New Orleans District
404 BNA Drive
Building 200 – Suite 500
Nashville, TN 37217
Telephone: (615) 366-7801
FAX: (615) 366-7802
(This letter replaces Warning Letter No. 2014-NOL-07 dated December 20, 2013)
December 31, 2013
WARNING LETTER NO. 2014-NOL-08
UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
James E. Scarbrough, Owner and President
Buchanan Manufacturing Inc. DBA Grow Agra
575 Cowpath Road
Buchanan, Tennessee 38222-3405
Dear Mr. Scarbrough:
On August 13 and 16, 2013, a U.S. Food and Drug Administration (FDA) investigator inspected your facility, located at 575 Cowpath Road, Buchanan, Tennessee. We found you have serious violations 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 21 CFR 120, renders the juice products adulterated within the meaning of Section 402(a)(4) of the Act [21 United States Code (USC) 342(a)(4)]. Therefore, your wheatgrass juice and wheatgrass/carrot juice blend products 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 Control Guidance through links on FDA’s Internet home page at http://www.fda.gov.
We received your response, dated August 28, 2013, concerning our investigator’s observations noted on the August 16, 2013, Form FDA 483, Inspectional Observations, (FDA 483) issued to you. Your response is addressed below in relation to each of the noted violations. These violations include, but are not limited to, the following:
1. You must have a HACCP plan that, at a minimum, lists all food hazards that are reasonably likely to occur, to comply with 21 CFR 120.8(b)(1). A food hazard is defined in 21 CFR 120.3(g) as “any biological, chemical, or physical agent that is reasonably likely to cause illness or injury in the absence of its control.” However, your firm’s HACCP plan entitled “GrowAgra Wheatgrass Juice and Wheatgrass/Carrot Juice” does not list the food hazards of:
a) Microbiological contamination which may occur when you reopen the (b)(4) containers after the 5-log reduction high pressure processing and repack the juice into one ounce bottles.
b) Allergens (i.e., wheat). Your firm’s labels include the statement “Allergen Wheat”; however, your firm’s HACCP plan does not address the food hazard of allergens. FDA recommends including a critical control point (CCP) at labeling to address this concern.
c) Clostridium botulinum at CCP 2. The hazard at this CCP would not be “pH level above (b)(4)”; the hazard would be Clostridium botulinum. The control measure for this hazard would be to reduce the pH to below 4.6.
2. You must include in your HACCP plan control measures that will consistently produce, at a minimum, a 5-log reduction of pertinent microorganisms, for a period at least as long as the shelf life of the product when stored under normal and moderate abuse conditions, to comply with 21 CFR 120.24(a); this 5-log reduction and final product packaging must be accomplished in a single facility to comply with 21 CFR 120.24(c). However, your firm’s HACCP plan entitled “GrowAgra Wheatgrass Juice and Wheatgrass/Carrot Juice” does not list measures that will achieve a 5-log reduction of the pertinent microorganism within a single facility operating under current good manufacturing practices.
FDA recognizes the wheatgrass and wheatgrass/carrot juice products you manufacture are sent to a separate facility in (b)(4) containers for (b)(4) to achieve 5-log reduction; and, the juice products are returned to your facility where you perform final packaging into 1 ounce-size containers. However, there is no provision in your HACCP plan for this (b)(4) treatment, nor does the processing and final product packaging occur within a single facility.
Your response does not specifically address the omission of the 5-log (b)(4) treatment from your HACCP plan, nor does it address the single facility requirement. You state you are in the process of establishing a (b)(4) process in (b)(4) to achieve the required 5-log reduction process in your products. You further explain in your response you expect to have this accomplished in (b)(4); however, you do not address product processed and distributed in the interim period. Additionally, your response does not indicate whether final packaging will then occur in the (b)(4) facility or whether your firm will continue to ship the products back to your Buchanan, Tennessee, facility for final packaging. Consequently, we do not consider your response to be adequate.
3. Your HACCP plan must list monitoring procedures and frequencies at each CCP adequate to control the hazard, to comply with 21 CFR 120.8(b)(4). However your HACCP plan entitled “GrowAgra Wheatgrass Juice and Wheatgrass/Carrot Juice” listed monitoring procedures and frequencies which were not adequate to control the hazards, as follows:
a) At “CCP (b)(4)” your HACCP plan lists a frequency of “(b)(4)” which is inadequate. This monitoring should occur with every lot of juice. Additionally, it was noted the title of this CCP lists “(b)(4)”; however, it should list that pH will not be above 4.6 for each lot of juice.
b) At “CCP (b)(4)” your HACCP plan lists a monitoring procedure of “(b)(4)” which is inadequate as it would not ensure the absence of metal in the juice. FDA recommends monitoring for metal detection to ensure: all product is going through the (b)(4); and periodic, e.g. hourly, documented checks are conducted with known standards of ferrous, non-ferrous, and stainless steel standards of an appropriate size to ensure the (b)(4) is functioning and detecting metal with the necessary sensitivity.
4. You must have appropriate, predetermined corrective action plans included in your HACCP plan, which would be conducted whenever there is a deviation from a critical limit, to comply with 21 CFR 120.8(b)(5). However, your corrective action plans for “GrowAgra Wheatgrass Juice and Wheatgrass/Carrot Juice” are not appropriate at CCPs listed in your HACCP plan, to comply with 21 CFR 120.10(a). Your HACCP plan includes corrective action procedures that do not address identifying and correcting the causes of the process deviation; and disposition of all product affected by the process deviation. Specific examples include:
a) At the CCP “(b)(4)” the corrective action does not address identification and correction of the problem which may have caused the deviation.
b) At the CCP “(b)(4)” the corrective action plan states “(b)(4)” This corrective action does not provide for adjusting the pH level in juice when it is above pH 4.6 or for identifying and correcting the cause of the failure to reach the lower pH.
In your response, you state your HACCP plan has been revised to include detailed corrective actions regarding “affected product.” Your response partially addresses these deficiencies as you describe that changes were made to your written HACCP plan; however, you did not provide a revised HACCP plan for evaluation. Therefore, we do not consider your response adequate.
This letter is not intended to include a comprehensive list of deficiencies at your facility. It is your responsibility to ensure your facility operates in full compliance with the Act, the Juice HACCP regulation, and the applicable federal regulations.
You should take prompt action to correct these violations, and you should establish procedures whereby such violations do not recur. Failure to correct these violations may result in regulatory action without further notice, including seizure or injunction.
You should notify this office in writing, within fifteen (15) working days from receipt of this letter, of the specific steps you have taken to correct the noted violations, including an explanation of each step taken to prevent recurrence. You should include in your response documentation, such as copies of your Juice HACCP Hazard Analysis, Juice HACCP plans, process controls for 5-log reduction of pertinent microorganisms, or other useful information which would assist us in evaluating your corrections. If corrective actions cannot be completed within 15 working days, state the reason for the delay and the time within which corrections will be completed.
Section 743 of the Act (21 USC 379j-31) authorizes FDA to assess and collect fees to cover costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees [21 USC 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Please address your reply to Rebecca A. Asente, Compliance Officer, at the address above. If you have questions regarding the contents of this letter, please contact Ms. Asente at (504) 832-1290, extension 1104.
Patricia K. Schafer
New Orleans District