Inspections, Compliance, Enforcement, and Criminal Investigations
Interior Alaska Fish Processor 3-20-2009
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
March 20, 2009
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 09-14
Virgil L. Umphenour, President/Owner
Interior Alaska, Fish Processor
2400 Davis Road
Fairbanks, Alaska 99701
Dear Mr. Umphenour:
We inspected your seafood processing facility, located at 2400 Davis Road, Fairbanks, Alaska, on November 18, 29, 20, and 21, 2008. 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 hot and cold smoked fish 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 implement the monitoring procedures and recordkeeping system that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b), (c)(4) and (c)(7). However, your firm did not monitor and record the critical limits at the "Smoke Fish" critical control point as listed in your HACCP plan for "Smoked salmon/halibut". Specifically, your firm was found not to be monitoring and recording the internal temperature of the "largest piece" of fish in the "coolest part of smoker" continuously with an "Internal probe" at to control "pathogens and Clostridium botulinum" as listed in your plan. During our inspection, we found that the smoker probe and recorder chart that would have been used for monitoring and recording these critical limits were not operative.
2. You must implement.the record keeping listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(7). However, your firm did not record monitoring observations at the "Brining" critical control point to control the hazard of Clostridium botulinum growth and toxin production as listed in your HACCP plan for "Smoked salmon/halibut". Specifically, your firm did not maintain monitoring records documenting the brining of batches #B32108, #704, #705, and #B32505.
3. You must have a HACCP plan that lists the critical control points, to comply with 21 CFR 123.6(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 "Cold Smoked Fish" does not list the critical control point of refrigerated storage for controlling the food safety hazard of pathogen growth and toxin production in the finished product.
4. You must have a HACCP plan that 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 "Smoked salmon/halibut" does not list a temperature critical limit that you intend to monitor and control at "Package finished product" critical control point to control Clostridium botulinum during finished product storage. Specifically, your plan lists "Label Statement of temp requirements to store below 38 degrees". However, there is no indication that this is the temperature you intend as your critical limit during refrigerated storage of the finished product. In addition, your monitoring procedure indicates that you intend to monitor and record storage temperatures daily. Please be advised that because pathogen growth is a significant hazard at the refrigerated storage critical control point and can be accelerated by small increments of temperature abuse, visually monitoring the cooler temperature daily is not adequate to control the hazard. FDA recommends the use of a continuous temperature monitoring and recording device in order for your firm to have the capability to assess any temperature deviations that may occur during any 24 hour period.
5. You must have a HACCP plan that lists monitoring procedures and their frequencies for each critical control point to comply with 21 CFR 123.6(c)(4). However, your firm's HACCP plan for" Smoked salmon/halibut" does not list the monitoring procedures or frequency at the "Brining" critical control point to ensure that your firm consistently meets the critical limit of 24 for the hydrometer reading to associated with brine concentration to control Clostridium botulinum growth and toxin production.
In addition, your HACCP plan for "Cold Smoked Fish" does not list a critical limit associated with a hydrometer value and/or any monitoring activity associated with brine concentration at the Brining critical control point to control Clostridium botulinum.
6. 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 "Smoked salmon/halibut" at the "Smoke fish" critical control point to control pathogen survival through cooking is not appropriate. Specifically, your listed corrective action plan does not describe the steps to be taken to ensure that the cause of the deviation is corrected.
In addition, your corrective action plan for "Smoked salmon/halibut" at your refrigerated storage critical control point control pathogen growth and toxin production does not describe the steps to be taken to ensure that (1) no product enters commerce that is either injurious to health or is otherwise adulterated as a result of the deviation; and (2) the cause of the deviation is corrected.
Also, with respect to your HACCP plan for "Cold Smoked Fish," your corrective action plan at your "Brine" critical control point to control Clostridium botulinum growth and toxin production in finished product does not describe the steps to be taken to ensure that (1) no product enters commerce that is either injurious-to health or is otherwise adulterated as a result of the deviation; and (2) the cause of the deviation is corrected.
7. 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; and the 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. an employee, who was observed coiling a hose that had been picked up off the floor and then was observed to handle tubs of brined salmon portion without first washing and sanitizing his hands;
b. an employee, who was observed to handle the exterior base of a rolling plastic garbage can used as brining tub and then process chum salmon pieces without first washing and sanitizing his hands;
c. rolls of plastic box and tote liners stacked on the concrete floor of your fiber storage area; and
d. a batch of brine in an uncovered roe agitation tan, which was exposed to contamination from splash, dust and airborne contaminates during the entire four day period of the inspection.
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 written reply to the Food and Drug Administration, Attention: Michael J. Donovan, Compliance Officer, 22201 23rd Drive SE, Bothell, WA 98021-4421. If you have any questions regarding this letter, please contact Mr. Donovan at (425) 483-4906.
Charles M. Breen
Copy of FDA 483
cc: ADEC, with disclosure statement