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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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E R K Distributors LLC. 10/28/13


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

Public Health Service
Food and Drug Administration
 Detroit District
300 River Place
Suite 5900
Detroit, MI 48207
Telephone: 313-393-8100
FAX: 313-393-8139



October 28, 2013
ERK Distributors, LLC
Mr. Ronald J. Pinto, Owner
301 Hacker Street, Unit
Rochester Hills, MI 48037-2636
Dear Mr. Pinto:
We inspected the seafood processing operations at your facility located at 301 Hacker Street Unit 5, Rochester Hills, Michigan on September 24-25, 30 and October 1-2, 2013. We found that you have serious violations of the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products 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). Accordingly, your Shrimp Egg Rolls, Shrimp & Pork Egg Rolls and Seafood & Cream Cheese Calzones 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 Seafood HACCP regulation, and the Fish and Fisheries Products Hazards & Controls Guidance: 4th Edition (the Hazard Guide), through links in FDA's home page at www.fda.gov.
Based on our review of the inspectional findings, we find that you have the following serious deviations:
1.    You must conduct or have conducted for you, a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur to occur, to comply with 21 CFR 123.6(a) and (c)(1). Additionally, you must implement a written HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(b). A food safety hazard is defined in 21 CFR 123.3 (f) as any biological, chemical, or physical property that may cause a food to be unsafe for human consumption. 
Your firm has not conducted a hazard analysis or implemented a HACCP plan for the following fish and fishery products that you manufacture:
a.    Shrimp Egg Roll
b.    Shrimp & Pork Egg Roll
c.    Seafood & Cream Cheese Pierogi
d.    Seafood & Cream Cheese Mini Calzones
2.    You must adequately monitor sanitation conditions and practices during processing to comply with 21 CFR 123.11(b). However, your firm has failed to monitor the prevention of cross-contamination; the maintenance of hand washing facilities and the protection of food and food packaging materials and food contact surfaces. For example, FDA Investigators noted: 
a.    On September 25, 2013, the manufacturing of Shrimp Egg Rolls (containing shrimp, an allergen) was observed taking place on a stainless steel table in the egg roll production room. The manufacturing of Vegetable Egg Rolls, a non-shrimp/allergen product, was observed to immediately follow on the same surface without a cleaning/sanitizing step in between. Shrimp is not listed on the Vegetable Egg Roll label.
b.    On September 24 and 25, 2013, the soap dispensers at the hand washing stations in the egg roll production room and the bathroom were observed to be empty.
c.    On September 25, 2013, the utensils and fryer observed in use for Shrimp Egg Roll production do not appear to be cleaned regularly, and have a black sludge build-up. Additionally, during the inspection a firm’s official stated these utensils are not routinely cleaned.
d.    On September 24 and 25, 2013, the filling for Shrimp Egg Rolls was observed being stored in white bins with holes drilled through the bottoms to allow for draining. Black residue was observed in the drain holes of the bins, directly before the egg roll mixture was introduced for overnight storage.
e.    On September 25, 2013, employees were observed touching unclean racks, stools, cardboard boxes, and other non-food contact surfaces, then handling food without washing and/or sanitizing their hands.
f.    On September 24 and 25, 2013, at least 20 metal trays containing in-process food items utilized during this inspection, to include: shredded cheese, egg rolls, potato filling, and baked potato skins, were observed being stored uncovered in your firm’s cooler. This cooler was noted to have mold-like residue and suspended condensate drips formed on the inside, directly above the uncovered food items.
g.    On September 24 and 25, 2013, an employee with facial hair was observed manufacturing Shrimp and Vegetable Egg Rolls and Potato, White Cheese, and Potato & Cheddar Pierogis without wearing a beard net.
In addition, in accordance with 21 CFR 123.10, HACCP plan development, reassessment, modification and record review must be performed by an individual that has completed training in applications of HACCP principles to fish and fishery product processing at least equivalent to that received under standardized curriculum recognized as adequate by the U.S. Food and Drug Administration, or who is otherwise qualified through job experience to perform these functions.  Your firm does not have anyone trained in seafood HACCP or otherwise qualified through job experience to perform seafood HACCP functions.
This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and the seafood HACCP regulation (21 CFR Part 123). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations. We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation such as HACCP and verification records, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
Your response should also include updated labeling for your firm’s products to include: Potato Pierogi, Potato-Cheddar-Bacon Pierogi, Potato & Cheddar Pierogi, White Cheese Pierogi, Seafood & Cream Cheese Pierogi, Kraut with Mushrooms Pierogi, Mini Calzones Pizza, Mini Calzones Seafood & Cream Cheese, Bacon & Cheddar Twice Baked Potato, and Broccoli & Cheddar Twice Baked Potato. In addition, you should submit documentation to demonstrate that your firm (b)(3)(A).  Please send your reply to the U.S. Food and Drug Administration, Attention: CDR Kimberly Martin, Compliance Officer, 300 River Place, Suite 5900, Detroit, MI 48207.
Section 743 of the Act (21 U.S.C. § 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 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.
If you have questions regarding any issues in this letter, please contact CDR Kimberly Martin at (317) 226-6500 ext. 116.
Glenn T. Bass
District Director
Detroit District Office