Inspections, Compliance, Enforcement, and Criminal Investigations
Inland Meats, Inc. 11/4/10
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
22201 23rd Drive SE
Bothell, WA 98021-4421
November 4, 2010
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 11-02
Daniel M. Mullenix, President
Inland Meats, Inc.
1222 North Regal Street
Spokane, Washington 99202
Dear Mr. Mullenix:
We inspected your food processing facility, located 1222 North Regal Street, Spokane, Washington, on July 21 and 22, 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, including the sanitation control procedures under 21 CFR 123.11, 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 salmon products in impermeable vacuum packaging 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 "Fresh Seafood "Vacuum Packing in Plastic" does not list a critical control point for controlling the food safety hazard(s) of Clostridium botulinum growth and toxin formation throughout the distribution of the vacuum packaged product.
We note that your revised HACCP plan, which was faxed on July 29, 2010, lists a single critical control point of "Halibut, Salmon"; these are products, and not appropriate processing steps as defined in 21 CFR 123.3(b).
The oxygen transmission rate (OTR) of your packaging as listed from the packaging manufacturer, (b)(4), is not sufficiently oxygen permeable to create an aerobic environment that will prevent Clostridium botulinum growth and toxin formation. In the absence of adequate permeable packaging, FDA recommends secondary controls (i.e., in addition to refrigeration), such as time/temperature integrators, for Clostridium botulinum growth and toxin formation. Chapter 13 of the Fish and Fisheries Products Hazards and Controls Guidance, Third Edition, can help you determine a method of control that is best suited to your process.
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 123.6(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 Seafood - Vacuum Packing in Plastic" does not list a critical limit at the Halibut Salmon critical control point to control Clostridium botulinum growth and toxin production. For reduced-oxygen packaged products in which refrigeration is the sole barrier to outgrowth of nonproteolytic Clostridium botulinum, and the spores have not been destroyed (e.g. vacuum-packaged raw fish), FDA recommends that the temperature be maintained at 38°F (3.3°C) or below from packing to consumption with time/temperature integrators.
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 plan for refrigerated, raw salmon and halibut products in oxygen impermeable packaging at the "Halibut Salmon" critical control point to control "Bacteriological/Pathogen Growth Clostridium botulinum" is not appropriate. Specifically, your listed corrective action plan does not address the cause of the deviation or the disposition of potentially unsafe product.
We acknowledge receiving your correspondence, sent by facsimile to the Seattle District Director on July 29, 2010, in response to the Form FDA 483, Inspectional Observations, issued at the conclusion of the inspection on July 22, 2010. Your correspondence consisted of a single page of a HACCP plan with the heading "INLAND MEATS, INC. WA 1496-SS, 1222 NORTH REGAL STREET, SPOKANE, WA 99202, FRESH SEAFOOD-VACUUM PACKING IN PLASTIC." Your response is inadequate in that your HACCP plan for refrigerated, vacuum packaged salmon and halibut does not ensure control of pathogen growth and toxin formation, including Clostridium botulinum toxin formation.
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.
Charles M. Breen
Copy of FDA 483
cc: WSDA, with disclosure statement