Inspections, Compliance, Enforcement, and Criminal Investigations
A G Specialty Foods, Inc 8/13/10
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
22201 23rd Drive SE
Bothell, WA 98021-4421
August 13, 2010
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 10-29
Sonia L. Andrus, Owner
Steven Andrus, Owner
A G Specialty Foods, Inc.
dba Napoleon Deli
439 Portland Avenue
Gladstone, Oregon 97027
Dear Mrs. and Mr. Andrus:
We inspected your seafood processing facility, located at 439 Portland Avenue, Gladstone, Oregon, on June 2-4, and 8, 2010. 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 tuna fish sandwiches in modified atmosphere packaging (MAP), and tuna fish sandwiches in plastic overwrap (non-MAP), 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, or have conducted for you, a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur for each kind of fish and fishery product that you process, and you must have and implement a written HACCP plan for each identified food safety hazard, to comply with 21 CFR 123.6(a) and (b). However your firm does not have a HACCP plan for tuna salad sandwiches in oxygen (impermeable packaging (i.e., modified atmosphere packing (MAP)) to control the food safety hazards of histamine formation, pathogen growth and toxin formation including Clostridium botulinum toxin formation, and allergens.
Clostridium botulinum toxin formation is a reasonably likely hazard when packaging, including films, provide an oxygen transmission rate (OTR) of less than or equal to 100 cc/m2/24 hour (e.g. 2 mil polyester). These materials are considered oxygen-impermeable, and can create anaerobic conditions that allow for C. botulinum growth and toxin formation. For refrigerated product in modified atmosphere packaging, FDA recommends strict temperature control (i.e. at or below 38°F) during storage and distribution, along with a secondary barrier to control C. botulinum growth and toxin formation. Secondary barriers may include product formulation factors such as: a water phase salt level of at least 5 percent, a water activity below 0.97, or a pH of 5.0 or less.
Allergenic reactions are a reasonably likely hazard associated with the egg, soy, wheat, fish, and milk ingredients used in manufacturing your sandwiches. Consequently, we recommend identifying allergens as a hazard associated with the sandwiches and including a critical control point for label review to ensure that the ingredients are, in fact, listed on the labels.
2. 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 a 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 "Ready to Eat, Fully Cooked, Not Shelf-Stable Tuna Fish Sandwich" in plastic over-wrap (non-MAP) does not list the food safety hazard of histamine formation at the "Refrigerate finished Products" critical control point, and allergenic substances, in addition to the tuna, such as eggs, soy, wheat, and milk at the Packaging and Labeling critical control point.
3. 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 lithe 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 "Ready to Eat, Fully Cooked, Not Shelf-Stable Tuna Fish Sandwich" in plastic over-wrap (non-MAP) lists a critical limit "(b)(4) degrees F." at the "Refrigerate finished Product" critical control point that is not adequate to control pathogen growth and histamine formation. FDA recommends a maximum storage temperature of 40°F (4.4°C) with continuous monitoring of cooler temperatures via a digital time/temperature data logger or recorder, and visual check of the instrument at least once per day to ensure that the device is operating properly.
4. 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 "Ready to Eat, Fully Cooked, Not Shelf-Stable Tuna Fish Sandwich" in plastic over-wrap (non-MAP) does not list the critical control point of in-process refrigerated storage for controlling the food safety hazard 'Of histamine formation and pathogen growth.
5. 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 safety of water, cleanliness of food contact surfaces, and storage and use of toxic chemicals with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110 as evidenced by a meat slicer, identified by your employee as clean and ready for use, with food residue on it; one unlabeled spray bottle containing an unidentified chemical in the dishwashing room; and a spray hose in the dishwashing room stored in a manner which did not ensure that back siphonage does not occur.
6. You must maintain adequate sanitation control records that, at a minimum, document monitoring and corrections set out in 21 CFR 123.11(b), to comply with 21 CFR 123.11(c). However, your firm did not maintain sanitation monitoring records for the maintenance of hand washing, hand sanitizing, toilet facilities, proper labeling, storage and use of toxic chemicals, and control of employee health conditions on August 7, 2009, October 10, 2009 and November 12, 2009. In addition, after reviewing sanitation monitoring records for fifteen production dates between July 7, 2009 through June 1, 2010, the FDA investigator also documented that you did not maintain complete sanitation monitoring records for the cleanliness of food contact surfaces, prevention of cross-contamination from insanitary objects, protection of food, food packaging material, and food contact surfaces from adulteration on July 7, 2009, July 8, 2009, November 11, 2009, January 7, 2010, and March 28, 2010.
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: Heidi Marks, Compliance Officer, Seattle District, 22201 23rd Drive SE, Bothell, Washington 98021-4421. If you have questions regarding any issues in this letter, please contact Compliance Officer Marks at (425) 483-4862.
Charles M. Breen
cc: ODA with disclosure statement