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WARNING LETTER

Iacofano's Group LLC MARCS-CMS 509873 — Mar 22, 2017

Iacofano's Group LLC - 509873 - 03/22/2017


Delivery Method:
UPS

Recipient:
Recipient Name
John L. Iacofano
Iacofano's Group LLC

1749 Sam Rittenberg Blvd

Charleston, SC 29407
United States

Issuing Office:
Atlanta District Office

United States


 

  

Black HHS-Blue FDA Logo

 

 

 
Atlanta District Office
60 8TH ST NE
Atlanta, GA 30309 

 

March 22, 2017
 
 
VIA UPS OVERNIGHT DELIVERY
 
 
John L. Iacofano, Owner
Iacofano’s Group LLC
1749 Sam Rittenberg Blvd.
Charleston, SC 29407
 
WARNING LETTER
(17-ATL-06)
 
Dear Mr. Iacofano,
 
The U.S. Food & Drug Administration (FDA) inspected your airline catering and institutional meal manufacturing facility located at 1749 Sam Rittenberg Blvd, Charleston, SC 29407 on August 15 through September 9, 2016. During our inspection, FDA collected environmental samples from various areas in your processing facility, including areas that are in close proximity to food and food contact surfaces.  One of the environmental swabs collected from a food contact surface in your facility yielded Listeria monocytogenes (L. monocytogenes), a human pathogen. Additionally, FDA investigators observed serious violations of the Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110)[1] Therefore, we have determined that the products produced at your airline catering and institutional meal manufacturing facility 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 have been prepared, packed or held under insanitary conditions whereby they may have been rendered injurious to health. Further, FDA conducted a review of your labeling for several of your ready to eat prepared meals that are sold to airlines as buy on board meals and found significant violations of the labeling regulations for foods, 21 CFR Part 101. These violations cause your meals to be misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343].  You may find the Act and its implementing regulations through links on FDA’s home page at www.fda.gov.
 
Presence of L. monocytogenes
 
FDA’s laboratory analysis of the environmental samples collected on August 16, 2016, confirmed that one of the 59 environmental swabs collected on a food contact surface, one of your food preparation tables, was positive for L. monocytogenes. 
 
L. monocytogenes is a pathogenic bacterium that is widespread in the environment and may be introduced into a food processing facility from raw materials, humans or equipment. Without proper controls, it can proliferate in food processing facilities where it may contaminate food. Consuming these contaminated foods can lead to a severe, sometimes life-threatening, illness called listeriosis, an atypical foodborne illness, which is a major public health concern, due to the severity of the disease, its high case-fatality rate, long incubation time, and tendency to affect individuals with underlying conditions.
 
We recommend that you review FDA’s draft guidance for industry titled “Control of Listeria monocytogenes in Ready-To-Eat Foods” for assistance in developing your Listeria control plan. The draft guidance can be found at:
 
CGMP Violations
 
Additionally, FDA investigators observed the following significant violations of the Current Good Manufacturing Practice regulations for foods at 21 CFR Part 110:
 
1.  You must hold foods which can support the rapid growth of undesirable microorganisms at a temperature that prevents the food from becoming adulterated in order to comply with 21 CFR 110.80(b)(3). However, our investigators measured an ambient temperature of 55 ºF in the walk-in refrigerator on 8/15/16 and 8/17/16. Products, such as ready-to-eat salads, that support the growth of pathogens, were stored in the refrigerator. Product temperatures in the walk in refrigerator ranged from 50- 53.3 ºF.
 
2.  You must assure effective measures are being taken to exclude pests from the processing areas and protect against the contamination of food on the premises by pests to comply with 21 CFR 110.35(c). However, our investigators observed:
  • Rodent pellets at various places throughout the facility.
  • A hole approximately 1” wide and 3” long leading directly to the outside of the exit door located to the right of equipment washing sink #2. This hole is large enough to allow entry of rodents into your facility.
  • Flying insects landing on food contact surfaces, prepared food, refuse, and raw goods in the food preparation area.
  • Two large dead brown insects resembling cockroaches under storage rack #5 in the dry storage area.
  • Multiple apparent stored product pests in the larval stage in the dry storage room under food preparation tables #1 and #3 as well as underneath food storage racks #1 and #2.
3.  You must manufacture food under such condition and controls as to minimize the potential for the growth of microorganisms, or for the contamination of food, to comply with 21 CFR 110.80(b)(2). However, during the inspection, the investigators observed:
  • An employee using his bare unwashed hand to scoop ice into plastic bags to be used for airline beverage service.  
  • Bread stored uncovered above the ovens for drying.
  • Condensate dripping onto mozzarella cheese and port wine cheese in freezer #1.
  • Muffins, roll, biscuits and other foods lying on the floor in #1 and #2 as a results of multiple pallets having been knocked over.
  • The ice machine with visible apparent mold in several spots on the interior surface, as well as a piece of duct tape with visible grime on the interior of the lid.
4.  In order to comply with 21 CFR 110.35, you must maintain buildings, fixtures, and other physical facilities of the plant in a sanitary condition and in sufficient repair to prevent food from becoming adulterated within the meaning of the Act. In addition, you must clean and sanitize utensils and equipment in a manner that protects against contamination of food, food-contact surfaces and food-packaging material. However: 
  • Floors in the production, packaging, and storage areas were deeply pitted and/or cracked. The pits and crack may serve as a reservoir of human pathogens, such as Listeria monocytogenes (L. monocytogenes)
  • Excessive grime, food waste debris, and dead insects as well as accumulated standing grey water in floor drains under the three compartment sinks in the food preparation area and other places throughout the facility. These conditions increase the risk of the growth and spread of human pathogens such as L. monocytogenes.
  • Approximately 20 unwashed pots and pans and miscellaneous utensils containing what appeared to be food residue were allowed to remain unwashed at equipment washing sink #1.
  • There was dirt and food resides on a deli meat slicer, a vegetable slicer, a mandolin slicer, pots, pans, knives, cutlery, bowls, and finished product containers.
  • Equipment and utensils with food debris stored in contact with clean equipment on equipment storage rack #2.
5.  In order to meet the requirements of 21 CFR 110.37 (b)(5), the plumbing in your facility must be of adequate size and design, be adequately installed and maintained to provide that there is not backflow from, or cross-connection between, piping systems that discharge waste water or sewage and piping systems that carry water for food or food manufacturing. However, our investigators observed the drain plumbing on the 3-compartment equipment washing sinks # 1 and 2, as well as the food preparation sink to be directly connected to the sewage system without an air break or back flow prevention device installed.
 
6.  In order to meet the requirements of 21 CFR 110.37 (e) you must have hand-washing facilities adequate and convenient, furnished with running water at a suitable temperature. However, our investigators observed three handwashing stations inside of the facility without any paper towels, and two stations did not have hand soap. Throughout the inspection the investigators observed employees eating, smoking, and drinking then returning to food preparation and packaging without adequately washing and drying their hands or without washing their hands at all.
  
Misbranding Violations
 
Your significant misbranding violations are as follows:
 
1.  Your Cheese Fruit Plate product is misbranded under Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that it is fabricated from two or more ingredients, but the label fails to bear the common or usual name of each ingredient, as required by 21 CFR 101.4 and fails to declare all sub-ingredients (ingredients of an ingredient in a finished product), as required by 21 CFR 101.4(b)(2):
  • Your Cheese Fruit Plate product does not contain any statement of ingredients and sub-ingredients as required by 21 CFR 101.4(a)(1) and (b)(2).  
The requirement to list component ingredients (or “sub-ingredients”) may be met by either parenthetically listing the component ingredients after the common or usual name of the multi-component ingredient, or by listing the component ingredients without listing the multi-component ingredient itself. Under the first alternative, the component ingredients must be listed in descending order of predominance within the multi-component ingredient; and under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food [21 CFR 101.4(b)(2)].
 
2.  Your Cheese Fruit Plate product is misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] in that the package does not provide the net quantity of contents on the principal display panel, as required under 21 CFR 101.7.
 
The above violations are not meant to be an all-inclusive list of violations that may exist in connection with your facility or your product labeling. It is your responsibility to ensure that your products comply with the Act and its implementing regulations.
 
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction. 
 
In addition, we offer the following comment:
 
We note that the place of business for the Cheese Fruit Plate product listed on the package does not include the street address in accordance with 21 CFR 101.5(d); however, we note that the street address may be omitted if it is shown in a current city directory or telephone directory.
 
(b)(3)(A)
 
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 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.
 
You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step which has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) days, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating corrections have been made. Please send your reply to the Food and Drug Administration, Attention: Janice L. King, Compliance Officer, 60 Eighth Street, NE, Atlanta, GA 30309. You may also use this contact to request and inspection. If you have any questions regarding this letter, please contact Ms. King at (843) 746-2990 x16.
 
Sincerely,
/S/ 
Ingrid A. Zambrana
District Director
Atlanta District Office
Southeast Region, Office of Regulatory Affairs
U.S. Food and Drug Administration
 

[1] Part 110 was modernized and codified in Subpart B of Part 117 by the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (21 CFR Part 117) (CGMP & PC rule). An establishment will continue to be subject to Part 110 until the Part 117 compliance date applicable to its business size. See http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334115.htm#Compliance_Dates for PC rule compliance dates.