Inspections, Compliance, Enforcement, and Criminal Investigations
Bartush-Schnitzius Foods Co 11/22/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
November 22, 2011
RETURN RECEIPT REQUESTED
John A. A. Rubi, President
Bartush-Schnitzius Foods Co.
425 E. Jones St.
Lewisville, TX 75057
Dear Mr. Rubi,
We inspected your seafood processing facility, located at 1137 N. Kealy St., Lewisville, Texas, on 7/20-22/11 and 8/22/11. 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 seafood salad products 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 www.fda.gov.
Your significant violations were as follows:
1. 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, 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 HACCP plan for your seafood salads, titled "HACCP Plan Form Category I Seafood Containing" does not list the critical control point ("CCP") of refrigerated finished product storage for controlling the food safety hazard of pathogenic bacteria growth and toxin production, and does not list a finished product labeling CCP for control of undeclared food allergens.
In regard to the lack of finished product refrigerated storage CCP, we received your reply letter dated September 9,2011, in which you state that you will review the Fish & Fisheries Guide and make appropriate changes to your current HACCP plan. However, you did not include a copy of a revised HACCP plan and we are therefore unable to evaluate the adequacy of this correction.
At the conclusion of the inspection you provided the investigator with an additional HACCP plan, titled "HACCP Plan Form All Catagories" [sic], which you reference in your September 9, 2011 letter. This plan lists a CCP with label monitoring at the point when you receive labels from outside suppliers, and, in the case of labels that you print in-house, at the point at which labels are modified. However, this control strategy is not adequate to control undeclared allergens. FDA recommends that this hazard be controlled at the step at which the label is applied to the finished product, and that a representative number of packages from each lot of finished product are examined. We suggest that you revise your HACCP plan for seafood salads to include a finished product labeling CCP.
2. You must have a HACCP plan that, at a minimum, lists the critical limits that must be met, 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 seafood salads lists critical limits at your "Receiving Surimi", "Manufacturing of Blended Ready-to-Eat Seafood Products" (blending step) and "Vegetable Processing" critical control points that are not adequate to control pathogenic bacteria growth and metal inclusion, respectively.
A. At the blending CCP, your plan lists the critical limit of (b)(4) to control pathogenic bacteria growth and toxin formation. However, the growth of several pathogenic bacteria, including Staphylococcus aureus, Salmonella species, Listeria monocytogenes, and E. coli, is not limited by a (b)(4).
In your September 9,2011 response letter you state that "The manufacturing process for these products is typically complete within (b)(4). Products are placed in the cooler which is maintained at less than (b)(4) degrees and are shipped within (b)(4)". However, according to your records for 7/20/11, you processed at least (b)(4) batches of seafood products, including (b)(4) Seafood Salad, (b)(4) Seafood Salad, and (b)(4) Seafood Salad, over a period of at least (b)(4) hours. Your production room's ambient air temperature is not monitored. Your production equipment is used continuously throughout the day without cleaning and sanitizing until production is completed. Review of HACCP records for other production days reveals that processing times for your seafood salads are frequently (b)(4) hours or more. Pathogenic bacterial growth can occur in and on equipment that is used continuously in a processing environment without temperature control, and can be a source of pathogens in product that is processed on that equipment, regardless of how long it takes to blend and package a single batch of product.
Your letter also states that "All product temperatures are measured prior to being shipped to ensure the temperatures do not exceed the critical limit". However, this temperature check is not listed in your plan, and since you did not state if there is also a time limit, or include a copy of a revised HACCP plan with your response, we cannot evaluate whether this temperature check is an effective means of control.
Chapter 12 of the Fish and Fishery Products Hazards and Control Guidance lists guidance for controlling pathogenic bacteria growth and toxin formation that can help you choose a method of control most suited to your process.
B. Your HACCP plan for seafood salads at the "Vegetable Processing" CCP lists the critical limit of "No metal particles in excess of (b)(4) mm". This critical limit is not adequate to control metal fragments that may cause trauma or serious injury. FDA recommends a critical limit at metal detection of "no detectable metal fragments" because foreign objects that are less than (b)(4) mm may cause trauma or injury to persons in special risk groups, such as infants, surgery patients, and the elderly.
Our review also found that your monitoring procedures and/or frequencies at the Vegetable Processing CCP are not adequate to control the hazards of metal inclusion, in that your monitoring frequency of "Continuous" and "Machine tested at least (b)(4). FDA recommends that your metal detection apparatus be checked at the start of each production day; further, as a verification activity, FDA recommends that the operation of the detection equipment be checked every four hours during operation, when processing factors change, and at the end of processing.
Additionally, please note that this CCP as listed in your HACCP plan is not reflective of your operation, in that your metal detection step occurs at the finished product packaging step, rather than at the (b)(4) step.
3. Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plans for your seafood salad products at the Receiving and Vegetable Processing critical control points to control pathogenic bacteria growth and metal inclusion hazards are not appropriate.
A. Specifically, your HACCP plan's corrective action at the Receiving CCP is "Refuse to accept shipment". This action is not adequate in that you must also take action to regain control over the operation after a critical limit deviation by discontinuing use of the supplier or carrier until evidence is obtained that the identified transportation practices have been improved.
B. Your HACCP plan's corrective action at the (b)(4) CCP of "Discard all product that has the possibility of metal inclusion" is not adequate because you must also take action to regain control over the operation after a critical limit deviation, by correcting operating procedures to ensure that product is not processed without an operating metal detection device, or attempting to locate and correct the source of the metal fragments found in the product, depending on the circumstances of the deviation.
4. 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, maintenance of hand washing facilities, and protection of food, food packaging material, and food contact surfaces from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate, and other chemical, physical, and biological contaminants with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110 as evidenced by:
A. There were no convenient hand-washing facilities in the processing area where ready-to-eat seafood salads are manufactured. In order for employees working in the seafood salad processing area to wash their hands, they must wash them outside of the processing room, then push a button to open a door, and then pass through a plastic curtain into the processing room.
B. On 7/20/11, water was observed to be dripping from an overhead cooling unit onto the vegetable dicer, which at the time was being used to dice celery for seafood salads.
C. On 7/20/11, during processing of ready-to-eat seafood salads, plastic bags were observed to be taped to the ceiling in your packaging room, and condensation was observed to be pooling in this plastic, including directly above a white bin filled with seafood salad.
D. On 7/20/11, white cutting boards that were being used to trim celery for use in seafood salads were found to be gouged and to contain brown residue.
In your September 9, 2011 letter you stated that you plan to have a hand sink installed within the production room by 10/15/2011. However, to date you have not provided evidence that installation of a hand sink has been accomplished as promised.
Your letter also states that by 12/1/2011 you plan to have the (b)(4) to (b)(4) and prevent condensation. However, this response is inadequate because you have not explained how you will effectively prevent condensation from dripping onto food and food-contact surfaces, such as the vegetable dicer, in the interim.
Your letter also states that you will clean the cutting boards and replace them as necessary. We will verify this correction at the time of the next inspection.
Additionally, further review of your HACCP plan reveals that it lists a receiving CCP that is not reflective of your operation and is not adequate to control pathogen growth and toxin formation as written. You stated during the inspection that you receive Surimi in the frozen state; however, your "Receiving Surimi" CCP lists a critical limit of "Ingredient Received (b)(4)". For refrigerated product (that is not frozen), this critical limit is not adequate to control pathogenic bacteria growth during transit. FDA recommends a critical limit of "All lots received are accompanied by transportation records that show that the product was held at or below an ambient or internal temperature of 40°F throughout transit". Or, for products delivered refrigerated with a transit time of four hours or less, we recommend a critical limit of transit time of less than four hours AND an internal temperature of the product at the time of delivery that does not exceed 40°F.
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.
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: Seri L. Essary, Compliance Officer, at the above letterhead address. If you have questions regarding any issues in this letter, please contact Ms. Essary at (214)253-5335.
Reynaldo R. Rodriguez, Jr.
Dallas District Director