Inspections, Compliance, Enforcement, and Criminal Investigations
Southern Foods Group, LLC 5/21/09
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|Atlanta District Office
60 Eighth Street, NE
Atlanta, GA 30309
May 21, 2009
VIA FEDERAL EXPRESS
Joseph J. Rodriquez, CEO
Southern Foods Group, LLC
3500 Old Battleground Road
Greensboro, NC 27410-2302
Dear Mr. Rodriquez:
We inspected your seafood processing facility, located at, 3500 Old Battleground Road, Greensboro, NC, on, 1/12 - 1/16/2009. 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, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123 & 110). 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 refrigerated vacuum packaged cooked ready to eat smoked seafood products, refrigerated pasteurized crabmeat, and raw uncooked whole fresh fin fish products are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious td 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 www.fda.gov.
We received your January 23, 2009 response to the FDA Form 483 and the attached revised HACCP plans for the products listed above. However, your response and the revisions to the HACCP plans do hot adequately address all of the observations in the Form 483. Your significant violations 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 have a HACCP plan that, at minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (c)(1). 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." However, your firm's HACCP plan for "Refrigerated vacuum packaged cooked ready to eat smoked seafood" does not list the food safety hazard of C. botulinum formation at the Receiving Critical Control Point.
2. You must conduct a hazard analysis to determine whether there are, food safety hazards that are reasonably likely to occur and; have a HACCP plan that, at a minimum, lists the critical control points for each of the identified food safety hazards to comply With 21 CFR 123.6(a) and (c)(2). A critical control point is defined in 21 CFR 123.3(b) as a "point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels." However, your firm's HAACP plan for "Fresh fin fish raw uncooked whole. H&G [headed & gutted], and fillet" does not list the critical control point (CCP) at finished product storage that is necessary to control the development of histamine in scormbrotoxin fish.
3. You must have a HACCP plan that, at a minimum, lists the critical limits that must be met at each of the critical control points to comply with 21 CFR 123.6(c)(3). A critical limit is defined in 21 CFR 123.3(c) as "the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate. or reduce to an acceptable level the occurrence of the identified food safety hazard." However, your firm's HACCP plan for "Fresh fin fish raw uncooked whole, H&G, and fillet" does not list a critical limit at the CCP of Receiving of fresh scombrotoxin (histamine) forming fish that is adequate to control the hazard of histamine development. The critical limit stated in your HACCP plan is that product is "received at (b)(4) or less or under ice, purchased from certified HACCP Dealer only." Taking internal temperature of incoming scombrotoxin fish alone is not an effective means of controlling the hazard of histamine development that might have occurred during transportation from the supplier, as this critical limit will not provide any information about the handling of the fish prior to receipt. We recommend that you include critical limits associated with the receipt of fish that will either require records indicating how the fish were handled during transit, such as continuous recording of temperature during transit of over 4 hours and that product is received refrigerated with no ice, as critical limits to control the hazard of histamine development, or that you perform histamine testing on the fish upon receipt.
4. You must have, a HACCP plan that, at a minimum, lists the procedures, and frequency thereof, that Will be used to monitor each of the critical control points to ensure compliance with the critical limits to comply with 21 CFR 123.6(c)(4). However, your firm's HACCP plan for "Refrigerated Pasteurized ',crabmeat" lists a monitoring procedure at the "Receiving" CCP that is not adequate to control C. botulinum. Specifically, your HACCP Plan lists "Temperature probe" as the monitoring procedure for the hazard of C. botulinum. This monitoring procedure is inadequate to control that hazard. FDA recommends a visual check for the adequacy of the ice upon receipt or the use of a continuous temperature monitoring device while product is in transit.
5. You must verify that your HACCP plan is adequate to control food safety hazards that are reasonably likely to occur to comply with 21 CFR 123.8(a). However, your firm's HACCP plan for "Refrigerated vacuum packaged cooked ready to eat smoked seafood" lists verification procedures of "weekly review" for all six critical control points. These procedures are not adequate to control the hazard of pathogen growth.
Additionally, your firm's HACCP plan for "Refrigerated vacuum packaged cooked ready to eat smoked seafood" failed to list periodic water phase salt analysis of the finished product as a procedure to verify the adequacy of the brining process. Results of salt water test results periodically performed by the North Carolina Department of Agriculture reveal that samples dating back to 1996 through 2000 and 2003 show water phase salt analysis results below 3.5%, which is the minimum required percent water phase, salt for the control of C. botulinum in smoked vacuum packaged seafood. Your firm did not take any corrective actions in the form of possible changes to the brining process and a review of affected products after receiving results below 3.5% or make any modifications to the HACCP plan for refrigerated vacuum packaged cooked ready to eat smoked seafood.
6. 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 condition and cleanliness of food contact surfaces, prevention of cross-contamination from insanitary objects, and protection of food, food packaging material, and: food contact surfaces from adulteration with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110, as evidenced by:
a. Ten fillet knives used to process various seafood and a knife sharpener were being stored in a drawer of an old metal file cabinet located outdoors behind the processing facility. In addition, a sharpening stone also used to sharpen the fillet knives was being stored on a large plastic barrel outdoors behind the processing facility. Processing employees were seen routinely using the knives to cut the tape on boxes of seafood, then cutting fish with them.
b. Three water hoses used for various activities in seafood processing room #1 were lying directly on the floor of the room.
c. A seafood processing employee was observed to enter the processing room from outside the facility and wash only one of his hands without using soap or hand sanitizer.
d. Open containers of various seafood on ice were observed being stored under shelves, constructed of uncovered wire mesh, on which cardboard boxes and wooden pallets were stored.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your products and/or enjoin your firm from operating.
As mentioned above, your recent revisions to the HACCP plans for the products addressed above, forwarded to us on January 23, 2009, were not adequate. We note the following inadequacies in the revised plans:
• The HACCP plan for "Refrigerated Pasteurized crabmeat" does not address calibration under the heading of records. Under the verification heading, there is no listing of a weekly review of records and the checking of the accuracy of the monitoring thermometers at least annually.
• The HACCP plan, for "Refrigerated fresh picked crabmeat" contains a number of inadequacies at the Receiving CCP. First, the plan does not specify what is to be (b)(4)F or less (a critical limit), the temperature of the product, or the temperature of the containers in which (the product is received. Also, we recommend the adequacy of ice on the products containers be listed as a critical limit. Under the "how" heading, the plan does not explain how the probe thermometer is to be used (i.e., check product temperature or check product container temperature). Furthermore, crabmeat receiving and the calibration records are not listed in the Records section. Finally, the Verification Section does not list the "weekly review of records" and does not include the "annual calibration of monitoring thermometers. We recommend you include these items in your HACCP plan for "Refrigerated fresh picked crabmeat."
Furthermore, the HACCP plan for "Refrigerated fresh picked crabmeat" lists a monitoring procedure of "Visual for the presence of ice, temperature probe." Please make sure that your visual ice check includes checking the adequacy of the ice. Also, temperature probing can be done at any point; however, probing should not be the only monitoring procedure used.
• The HACCP plan for "Refrigerated vacuum packaged cooked ready to eat smoked seafood" does not include thermometer calibration records and the weekly review of records as well as the calibration of thermometers at least annually or when dropped at any of the critical control points. The plan fails to list the continuous monitoring (24/7 day) system and the (b)(4) monitoring for the cooler temperature at the Storage CCP.
• The HACCP plan for the "Fresh fin fish raw uncooked whole, H&G, and fillet" does not include as a critical limit at the Receiving CCP the adequacy of ice covering the fish as the primary limit, which we recommend as opposed to listing "received a (b)(4) or less OR under ice. The plan also fails to list the adequacy of ice as a Monitoring procedure at the Receiving CCP, and fails to list calibration records and the calibration of thermometers at the Receiving and Storage CCPs.
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.
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, 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 and all applicable regulations.
Please send your reply to the Food and Drug Administration, Attention: Serene N. Ackall at the address in the letterhead. If you have questions regarding any issues in this letter, please contact Serene N. Ackall at 404-253-1296.
LaTonya M. Mitchell, Acting Director