Inspections, Compliance, Enforcement, and Criminal Investigations
Vicrossano Inc. 11/27/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD 20742
NOV 27, 2013
VIA EXPRESS DELIVERY
Ms. Rosette Rossano, President
2102 Cabot Street
Reference No. # 415200
Dear Ms. Rossano:
The U.S. Food and Drug Administration (FDA) inspected your food facility Vicrossano Inc.locatedat 2102 Cabot Street, Montreal, Canada on July 8-9, 2013. During that inspection, we found that you had serious violations from the Current Good Manufacturing Practice (CGMP) regulation, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110). At the conclusion of the inspection, the FDA investigator issued a FDA-483, Inspectional Observations, listing the deviations found at your facility. Based on the inspection findings, your food products are 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)] in that they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. You may find the Act and FDA’s regulations through links in FDA’s home page www.fda.gov.
We acknowledge receipt of your response sent via email on July 24, 2013. Your response included descriptions of your corrections to the observations on the FDA-483. In addition, you provided photos, with no descriptions, of some of your corrections via email on October 31, 2013. However, our evaluation of the documentation revealed that the response was not adequate, as further discussed below.
Your significant deviations are as follows:
1. Your firm failed to take effective measures to (b)(4) from the processing areas and to protect against the contamination of food on the premises by (b)(4), as required by 21 CFR 110.35(c). Specifically, (b)(4) were observed throughout the production and storages areas of the facility, and (b)(4) were observed in a covered container of roasted almonds that were to be ground into almond butter. In addition, you stated to our investigator that a (b)(4) came to the facility on a weekly basis and is trying to control the problem with (b)(4); however, your (b)(4) were observed (b)(4) and had not been replaced (b)(4).
In your response, you stated that you replaced the (b)(4); however, you did not provide evidence that you are taking effective measures to (b)(4) from your facility, such as changing the (b)(4) more frequently or changing peanut suppliers.
2. Your firm failed to clean food contact surfaces as frequently as necessary to protect against contamination, as required by 21 CFR 110.35(d). Specifically, your food contact surfaces are washed and sanitized only on a monthly basis. In addition, chronic residue build-up was observed on the interior surfaces of the metal wheeled carts used to move roasted and blanched peanuts to the grinding and bottling room.
In your response, you stated that you always clean the food contact surfaces inside and outside when you start U.S. production; however, during the inspection you told our investigator that you only wash and sanitize on a (b)(4). Furthermore, you did not provide documentation that your food contact surfaces are cleaned on a frequency necessary to protect against contamination.
3. Your firm failed to maintain buildings, fixtures, and other physical facilities of the plant in a sanitary condition and in sufficient repair to prevent food from becoming adulterated, as required by 21 CFR 110.35(a). Our investigator observed the following:
a. Dust accumulation and other extraneous materials hanging directly above roasted peanuts exiting the terminal end of the peanut cooler.
b. The almond roaster exit chute had an old piece of cardboard with heavy filth buildup that was used to divert almonds into the cooling unit.
c. The almond cooler had missing and peeling paint directly above where the almonds are cooled.
d. Ceramic burner heads in the middle of the almond roaster where almonds spin around during roasting were chipped.
Your response is inadequate because you did not provide evidence of your corrective actions, such as photos or documentation of cleaning or repairs.
4. Your firm failed to ensure that your facility is constructed in such a manner that floors, walls, and ceilings may be adequately cleaned, and kept clean and in good repair, as required by 21 CFR 110.20(b)(4). Our investigator observed the following:
a. The floors in the first floor bathroom and the upper level grinding/filling room were lined in cardboard.
b. Thick metal plates were welded together in production areas and some plates were curved up, which could allow for materials to collect underneath or to harbor pests.
c. The walls in the peanut roasting, cooling, and blanching room had peeling paint and plaster.
Your response is inadequate as you are still lining the floors with cardboard and have not provided evidence that your floors are cleanable. In addition, you did not provide corrective actions for the thick metal plates, or for the peeling paint and plaster on the walls. We note that you are moving to a new facility; however, while you are manufacturing in your current facility, you must ensure that the facility is being maintained in a manner that can be adequately cleaned.
5. Your firm failed to provide food handlers training in food handling techniques and food protection principles, as required by 21 CFR 110.10(c). Specifically, you stated to our investigator that you had not conducted training for your employees in 18 years.
In your response, you stated that you conduct training for new employees. This response is not adequate because, based on the conditions in the facility, proper cleaning and hygienic procedures were not being implemented.
You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these deviations and should include documentation that would assist us in evaluating your corrections. This should include information on any changes to your cleaning and sanitizing standard operating procedures (SOPs), and the frequency of such operations, to protect food against contamination. Responding in English will help to assist us in our review of your documentation. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations.
If you do not respond or if we find your response inadequate, we may take further action. For instance, we may take further action to refuse admission of your products under Section 801(a) of the Act (21 U.S.C. §381(a).
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 Good Manufacturing Practice regulation (21 CFR 110), and all applicable regulations. You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Additionally, Section 743 of the Act (21 U.S.C. 379j-31) authorizes 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 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 U.S.C. 379j-31(a)(2)(B)). For a foreign facility, FDA will assess and collect fees for re-inspection-related costs from the U.S. Agent for the foreign 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 consider providing a copy of this letter to your U.S. Agent.
Please send your reply to Food and Drug Administration, Attention: Sheena Crutchfield, Consumer Safety Officer, Office of Compliance, Division of Enforcement, Food Adulteration Assessment Branch (HFS-607), 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Ms. Sheena Crutchfield via email at email@example.com.
William A. Correll, Jr.
Office of Compliance
Center for Food Safety
and Applied Nutrition