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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Barcelona Nut Company 8/9/12

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Baltimore District Office
Central Region
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Telephone: (410) 779-5455
FAX: (410) 779-5707

FEI:1112567                                                                                                                                                                                                                                                                                                                

WARNING LETTER
CMS# 292777
 
Thursday, August 9, 2012
 
 
Certified Mail
Return Receipt Requested
 
Mr. Anthony C. Tsonis, Owner
Barcelona Nut Company
502 S. Mount St.
Baltimore, MD 21223
 
Dear Mr. Tsonis:
 
The U.S. Food and Drug Administration (FDA) inspected your manufacturing facility located at 502 S. Mount St., Baltimore, MD 21223 on February 14, 15, 21, 23, and March 2, 2012.  The inspection found significant violations of FDA’s Current Good Manufacturing Practice (CGMP) regulations in manufacturing, packing, or holding human food, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110). These violations cause the foods manufactured at your facility to be 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 been contaminated with filth or rendered injurious to health. You can find the Act and its implementing regulations on FDA’s home page www.fda.gov.
 
Specifically, our inspection of your facility revealed the following CGMP violations:
 
1.)    Your firm failed to clean food-contact surfaces, including utensils, and food-contact surfaces of equipment, as frequently as necessary to protect against contamination of food [21 CFR 110.35(d)]. Specifically, on February 14, 2012, employees were observed processing cashews in the roasting machine, followed by almonds. After the almonds had been loaded into the roasting machine, the investigator observed cashew pieces too numerous to count remaining on the roasting machine belt. In addition, debris from previously roasted products such as sunflower kernels, peanuts and cashews were observed on the surface, as well as in cracks and crevices in the roasting machine.
 
2.)    Your firm failed to take effective measures to exclude pests from processing areas and to protect against the contamination of food on the premises by pests, as required by 21 CFR 110.35(c). There was evidence of widespread rodent activity in, on, and near product in the shipping, finished good storage, and raw ingredient storage areas in your facility. Specifically, our investigator observed the following:
 
a.       At least three rodent excreta pellets (REPs) were observed on a shrink-wrapped pallet containing Barcelona Mixed Nuts in the shipping area. 
b.      At least twenty REPs were observed on and under one pallet and at least fourteen REPs on and under another pallet, both located in the shipping area.
c.       An apparent dead rodent and approximately eighteen apparent REPs on a glue trap located between the wooden slats of a pallet located along the northern wall of the finished goods area of your warehouse.
d.      At least twenty REPs were observed in or adjacent to a pile of split sunflower seeds on the floor of the western area of the finished goods area of your warehouse between six pallets of sunflower seed bags.
e.       At least twenty apparent REPs were observed on the floor near pieces of unidentifiable nuts located along the northeastern wall of the raw ingredient storage area.
 
Gaps in your facility that could potentially allow pests to enter were observed and cited during our previous inspection of your facility that took place October 6 through 15, 2009. Gaps in your facility were found in different locations during our most recent inspection. Your response to our most recent inspection states that you will be re-emphasizing daily inspections for all warehouses for caught mice, product spills, REPs, and proper storage of pallets, as well as initiating a monthly wall-to-wall sweep. Your response does not mention any routine examination of your facility to locate and address gaps that could potentially allow pests to enter.
 
This letter may not list all the violations at your facility. You are responsible for ensuring that all of your products are in compliance with the applicable statutes and regulations administered by FDA. You should take prompt action to correct these violations. Failure to promptly correct these violations may result in regulatory action by FDA without further notice. Such action includes seizure of your products and/or injunction.
 
We request that you notify this office in writing, within fifteen (15) working days of receipt of this letter. Your response should include the specific steps you have taken to correct the violations. If you can not complete all of the corrections within 15 working days, state the reason for the delay and the time within which corrections will be completed.
 
Your response should be directed to: Mr. Ernest F. Bizjak, Compliance Officer, U.S. Food and Drug Administration, Baltimore District Office, 6000 Metro Drive, Suite 101, Baltimore, MD 21215. If you have any questions, please do not hesitate to call Mr. Bizjak at (410)779-5715 or send him an email at ernest.bizjak@fda.hhs.gov.
 
Sincerely,
/S/ 
Evelyn Bonnin
District Director
Baltimore District Office