Inspections, Compliance, Enforcement, and Criminal Investigations
Registry Steaks and Seafood Ltd 10/8/09
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
550 West Jackson Blvd., 15th Floor
Chicago, Illinois 60661
October 8, 2009
RETURN RECEIPT REQUESTED
Mr. Anthony R. Migacz
Registry Steaks & Seafood Ltd.
7661 South 78th Avenue
Bridgeview, IL 60455
Dear Mr. Migacz:
The Food and Drug Administration (FDA) inspected your seafood processing facility, located at 7661 South 78th Avenue, Bridgeview, IL 60455, on April 28, April 30, May 4, May 6, May 13, May 21, June 3, and July 13, 2009. We found that you have serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and associated regulations. You can find the Act and regulations on FDA's website at www.fda.gov.
FDA collected samples of your Shell-On Shrimp, Peeled and Deveined Shrimp, and Cooked Tail-On Shrimp products during the inspection of your facility. These frozen shrimp products are adulterated within the meaning of Section 402(b)(4) of the Act [21 U.S.C. § 342(b)(4)], in that an ice glaze and/or a frozen "marinade" glaze containing water, citric acid, and salt, has been added to increase the products' bulk or weight. Section 402(b)(4) of the Act provides that a food is adulterated if any substance has been added or packed with it to increase its bulk or weight. Furthermore, your Shell-On Shrimp, Peeled and Deveined Shrimp, and Cooked Tail-On Shrimp are misbranded within the meaning of Section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)], and Section 4(a)(2) of the Fair Packaging and Labeling Act (FPLA) [15 U.S.C. § 1453(a)(2)], in that they fail to bear an accurate statement of the net quantity of contents because they include the weight of the ice glaze or frozen marinade in the net quantity of contents.
Section 403(e)(2) of the Act and section 4(a)(2) of the FPLA require food to bear an accurate statement of the net quantity of contents. Overstating the net quantity of contents (such as including the weight of ice glaze or marinade) misbrands the products under these sections, as discussed in FDA's 1991 letter to seafood manufacturers regarding the fraudulent practice of including glaze (ice) as part of the weight of frozen seafood. You can find the letter on FDA's website at:
Although you indicated that you plan to (b)(4) at your facility, you provided no evidence that this process has in fact been discontinued.Furthermore, you indicated that you will continue to receive, re-pack, and sell frozen shrimp products that have undergone the same marinating process at other locations. As discussed above, any frozen seafood product that includes the weight of an ice glaze or marinade in its net quantity of contents is misbranded under section 403(e)(2) of the Act and section 4(a)(2) of the FPLA in that it does not bear an accurate statement of the net quantity of contents.
In addition, FDA collected samples of your product labeled as "Grouper Fillets, Ingredients: Grouper" during the inspection of your facility. This product is adulterated within the meaning of Section 402(b)(2) of the Act [21 U.S.C. § 342(b)(2)] in that Northern Rock Sole has been substituted for Grouper. Furthermore, your product labeled as "Grouper Fillets, Ingredients: Grouper" is misbranded within the meaning of Section 403(b) of the Act [21 U.S.C. § 343(b)] in that it is offered for sale under the name of "Grouper Fillets" and lists as its ingredients "Grouper" but is in fact Northern Rock Sole.
We also found that you have serious violations of the Seafood Hazard Analysis and Critical Control Point 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 Act [21 U.S.C. § 342(a)(4)]. Accordingly, your frozen shrimp products Shell-On Shrimp, Peeled and Deveined Shrimp, and Cooked Tail-On Shrimp 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 through links in FDA's home page at http://www.fda.gov.
Your significant violations of 21 CFR 123 are as follows:
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, and you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a). However, your firm does not have a HACCP plan for your frozen shrimp products to control the food safety hazard of sulfites. For additional information regarding control strategies associated with the hazard of sulfites and sulfite labeling, please refer to Chapter 19 of the Fish and Fisheries Products Hazards and Controls Guidance: 3rd Edition.
2. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR Part 110, to comply with 21 CFR 123.11(b). However, your firm did not monitor the prevention of cross contamination from insanitary objects to food, food packaging material, and other food contact surfaces; the maintenance of hand washing, hand sanitizing, and toilet facilities; the protection of food, food packaging materials, and food contact surfaces from adulteration with contaminants; and the proper labeling, storage, and use of toxic compounds, with sufficient frequency to ensure control, as evidenced by:
a. On 04/30/09, an employee was observed using a hose to spray water on the band saw machine in the production area. The water from the hose was observed spraying off the soiled band saw equipment and onto open frozen shrimp product.
b. On 04/28/09 and 05/13/09, the hand sink in the major production area of the firm had a maximum hot water temperature of 54 degrees Fahrenheit. On 05/21/09, the hand sink in the major production area of the firm had a maximum hot water temperature of 57 degrees Fahrenheit.
c. On 05/13/09, no method for drying hands was available for use after hand washing at the production room hand sink.
d. On 04/28/09, red crates used during the shrimp processing and band saw blades were observed on the rusted hot water heater stand next to bleach and a rodent trap.
e. On 04/28/09 and 04/30/09, toxic chemicals, such as Bleach, were observed in multiple areas throughout the firm, including:
i on the 3-compartment sink next to utensils identified as clean,
ii in the production area on a shelf with ingredients such as citric acid and salt, and
iii on the hot water heater stand next to band saw blades stated to be clean.
f. On 05/13/09, an employee was observed using a (b)(4) cleaner with bleach on the floors in the production and material storage areas of the firm. The employee was observed dousing the floor with the cleaner without mixing the cleaner with the instructed amount of water for proper usage and toxicity of the sanitizing agent.
g. On 05/13/09, an unlabeled spray bottle containing a light yellow liquid was observed on a shelf in the smaller production area with cleaning supplies.
h. On 04/28/09, 04/30/09, 05/04/09, 05/06/09, and 05/13/09, packing materials were used as a barrier and wall between the employee personal area and the production area.
i. The firm utilizes (b)(4) Glass Cleaner as a general all purpose cleaner, including use on food contact tables in the production areas. (b)(4) Glass Cleaner does not contain soaps or sanitizing agents, and is therefore not appropriate as a cleaner for food contact surfaces.
j. On 04/28/09,04/30/09,05/04/09,05/06/09,05/13/09, and O5/21/09, drain tubes from the vacuum packaging machine were observed in the smaller processing area lying across the center of the floor to the floor drain. A puddle of water was observed near and around the floor drain.
k. On 04/30/09, 05/13/09, and O5/21/09, employees were observed storing production trays on trash receptacles in the production areas. The trays were being used to re-pack fish and shrimp products.
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 actions you are taking to correct these violations. You should include in your response documentation such as copies of your revised seafood HACCP plans, temperature control and production monitoring records, sanitation monitoring records, related sanitation corrective actions, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining violations.
This letter may not list all the violations at your facility. You are responsible for ensuring that you are in compliance with all FDA regulatory requirements and that your processing plant operates in compliance with the Act, the seafood HACCP regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act, the FPLA, and all applicable regulations.
Please send your reply to the Food and Drug Administration, Attention: Rosemary Sexton, Compliance Officer, at the address above. If you have any questions regarding any issues in this letter, please contact Ms. Sexton at 312-596-4225.
Scott J. MacIntire