Inspections, Compliance, Enforcement, and Criminal Investigations
Metro Produce Distributors, Inc. 6/14/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Minneapolis District Office
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 334-4100
FAX: (612) 334-4142
June 14, 2012
RETURN RECEIPT REQUESTED Refer to MIN 12 – 36
Metro Produce Distributors, Inc.
2700 E. 28th Street
Minneapolis, Minnesota 55406
Dear Mr. Anderson:
We inspected your facility located at 2700 E. 28th Street, Minneapolis, Minnesota, on February 24, 27 and March 1, 2012. We found you are in violation of the Federal Food, Drug, and Cosmetic Act (the Act) in that you are in violation of the juice Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations (21 CFR), Part 120. These deviations cause your 100% juices (orange, grapefruit, tangerine) to be in violation of section 402(a)(4) of the Act. You can find this Act and the juice HACCP regulation through links on FDA’s home page at www.fda.gov.
The observations of concern to us are as follow:
1. Your HACCP plan does not include 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 your 100% grapefruit and 100% tangerine juices when stored under normal and moderate abuse conditions, for the pertinent microorganism as required in 21 CFR 120.24(a). For example, you manufacture 100% fresh-squeezed grapefruit juice and 100% fresh-squeezed tangerine juice using a surface treatment of the fruit for which you have not conducted a validation study of a 5-log reduction of the pertinent microorganism for these products.
Your response dated 3/13/12 included a validation study for the surface treatment of your 100% orange juice product which you also apply to your 100% fresh-squeezed grapefruit juice and 100% fresh-squeezed tangerine juice. There is not enough data provided in the validation study to ensure the surface treatment process achieves a 5-log pathogen reduction. FDA reviewed the proposed study and has a number of comments that need to be addressed:
A. Does the product “(b)(4) Fruit and Vegetable Wash” have an EPA-approved label? The pH of the treatment solution should correspond with label directions.
B. The validation study can be improved in order to fully understand the fate of the salmonellae inoculated onto the fruit surface. The study does not include inoculation of the stem-scar which is known to be the most difficult area of the fruit to disinfect after inoculation.
C. It is unclear how much the salmonellae population decreased due to the washing effect independent of the heat and sanitizer. Is there any background flora that would have affected these results?
D. It is unclear how much the acidic solution adds to the overall log reductions. It would be helpful for (b)(4) to better characterize the thermal resistance of the salmonellae in his study to determine D and z-values in the acidic solution used for orange treatment. Additionally, (b)(4) should remain cognizant of the greater survival of salmonellae when inoculated on the stem-scar.
E. The study proposed should be much more comprehensive in nature to better articulate the number of log reductions expected. A better description of the thermal inactivation characteristics of the Salmonella strains in the conditions of the study is needed. Additionally, numbers from all of the experiments conducted as part of the study should be provided to determine variability and effectiveness.
2. You must analyze your finished grapefruit juice and tangerine juice products for biotype I Escherichia coli when you rely on a treatment that does not come into direct contact with all parts of the juices that you manufacture as required in 21 CFR 120.24 and 21 CFR 120.25. However, you do not analyze your finished grapefruit juice and tangerine juice products for biotype I Escherichia coli.
3. You did not implement the monitoring procedures listed in your HACCP plan as required in 21 CFR 120.8(a). For example, on 2/24/12 you manufactured fresh-squeezed orange juice from fruit that was not (b)(4) as required by your plan. Furthermore, you did not monitor (b)(4) as required by your plan.
4. The monitoring procedures and frequencies of performing procedures listed in your HACCP plan at the critical control points of (b)(4) do not ensure compliance with those critical limits as required in 21 CFR 120.8(b)(4). For example, your HACCP plan does not list the frequency of visual checks for those critical control points.
5. The corrective actions listed in your HACCP plan at the critical control points of (b)(4) have not been developed in accordance with 21 CFR 120.10(a) to ensure the deviation was corrected as required in 21 CFR 120.8(b)(5). For example, the corrective actions listed at each of these critical control points do not address the cause of the process deviation.
6. You did not verify that your HACCP plan is being implemented according to design by review of monitoring records within one week of the day that the records are made as required in 21 CFR 120.11(a)(1)(iv). For example, during this inspection the “Juice Pasteurization Record” was initialed by management but was not dated.
7. You must have sanitation standard operating procedure (SSOP) records that, at a minimum, document monitoring of sanitation conditions and practices during processing and corrections of conditions and practices that comply with appropriate provisions in 21 CFR 120.6(c) and 21 CFR 120.12(a)(1). However, your firm does not maintain SSOP records.
8. You must monitor conditions and practices during processing with sufficient frequency to ensure conformance with current good manufacturing practice regulations as required in 21 CFR 120.6(b). However, your firm did not monitor prevention of cross-contamination from insanitary objects to food, food packaging material, and other food contact surfaces; protection of food, food packaging material, and food contact surfaces from adulteration; and proper labeling, storage and use of toxic compounds with sufficient frequency, as evidenced by:
A. 21 CFR 120.6(a)(3) – Cross-contamination from insanitary objects to food, food packaging material, and other food contact surfaces: On 2/24/12 employees were touching and handling packaging materials, juicing equipment and towels, after which they handled sanitized, surface-treated oranges and the threaded neck of juice bottles. Gloves were not changed or sanitized prior to handling the oranges or bottles. Also, employees were storing clean, unused plastic gloves in their smock pockets prior to use.
B. 21 CFR 120.6(a)(5) – Protection of food, food packaging material, and food contact surfaces from adulteration: On 2/24/12 cleaning chemicals and detergent were mixed together and then used to clean and sanitize bins. Label directions for the chemicals stated that the chemicals were not to be mixed with detergent.
C. 21 CFR 120.6(a)(6) – Proper labeling, storage, and use of toxic compounds: On 2/24/12 cleaning chemicals were stored on the production floor adjacent to processing equipment rather than in a secured area.
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.
You should notify this office in writing within 15 working days of receipt of this letter of any steps you have taken or will take to correct the noted violations and to prevent their recurrence. If corrective actions cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Failure to promptly correct these deviations may result in regulatory action without further notice. Such actions include seizure and injunction.
Section 743 of the Act (21 U.S.C. § 379j-31) authorized FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified non-compliance 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 U.S.C. § 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 non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Your reply should be directed to Compliance Officer Demetria L. Lueneburg at the address indicated on the letterhead.
Michael Dutcher, DVM