Inspections, Compliance, Enforcement, and Criminal Investigations
Pacific Northwest Best Fish Company 19-Jul-05
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
22201 23rd Drive SE
Bothell, WA 98021-4421
July 19, 2005
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 05-26
Dan Evans, President
Pacific Northwest Best Fish Company
24415 NE 10th Avenue
Ridgefield, WA 98642
Dear Mr. Evans:
We inspected your firm, located at 24415 NE 10th Avenue, Ridgefield, Washington, on March 15-17, 2005. We found that you have serious deviations from the seafood Hazard Analysis and Critical Control Points (HACCP) regulation, Title 21, Code of Federal Regulations , Part 123 (21 CFR Part 123) and the Current Good Manufacturing Practices (cGMP) requirements for foods, 21 CFR Part 110. In accordance with 21 CFR 123.6(g), failure of a processor to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of this part, renders the 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 ready to eat, vacuum packaged, smoked salmon products are adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. You can find the Act, the Seafood HACCP regulation, the cGMP regulation, and the FDA Fish and Fisheries Products Hazards and Controls Guidance through links in FDA's homepage at www.fda.gov.
Your significant deviations were as follows:
1. You must adequately monitor sanitation conditions and practices during processing, to comply with 21 CFR 123.11(b). However, your firm did not monitor the following areas of sanitation with sufficient frequency to ensure control:
a. Prevention of cross-contamination from insanitary objects to food, food packaging material, and other food contact surfaces, as evidenced by observation of an employee who, while de-boning smoked fish prior to packaging, changed the station on the radio, which had a build up of product residue, and then went back to de-boning without first washing and sanitizing her hands.
b. 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, as evidenced by a bottle of [redacted] Gear Oil stored on a shelf next to and above packaged ingredients.
c. Condition and cleanliness of food contact surface, including outer garments, as evidenced by a soiled employee apron hanging in the finished product packaging room.
d. Exclusion of pests from the food plant, as evidenced by
i. Over 30 rodent droppings in the NE corner of the finished product packaging room under the stairs;
ii. Over 15 rodent droppings in the finished product packaging room by the door at the top of the stairs; and
iii. Six rodent droppings on the attic side of the door leading from the attic into the finished product packaging room.
In addition, you did not correct sanitation deficiencies in a timely manner. Specifically, your pest monitoring record from [redacted] dated March 2, 2005, indicated there were rodent droppings at the top of the stairs. We observed droppings in the same location on March 15, 2005. Based on this, it appears the original sanitation deficiency has remained uncorrected or has recurred without timely correction.
2. You must maintain sanitation control records that, at a minimum, document monitoring and corrections to comply with 21 CFR 123.11(c). However, from the time of our previous inspection, which ended July 13, 2004, until March 7, 2005, your firm did not maintain sanitation monitoring records for the following areas of sanitation required for the processing of your hot smoked salmon:
- safety of water that comes into contact with food or food contact surfaces, including water used to manufacture ice;
- condition and cleanliness of food contact surfaces;
- prevention of cross-contamination from insanitary objects;
- maintenance of hand washing, hand sanitizing, and toilet facilities;
- protection of food, food packaging material, and food contact surfaces from adulteration;
- proper labeling, storage and use of toxic chemicals; and " control of employee health conditions.
Though a sanitation record was maintained for March 7 and 8, 2005, that record was not complete, not initialed as having been reviewed and covered only the cleanliness of certain food contact surfaces.
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 in order 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 hot smoked, vacuum packaged salmon lists critical limits of brine time, brine temperature, and brine salinity, at the "BRINING" critical control point that, by themselves, are not adequate to control pathogens, including Clostridium botulinum.
We note that the adequate critical limits are specified in the Standard Operating Procedures and the master recipe serves as a record of compliance for these limits. The Standard Operating Procedures and the master recipe may be considered part of the HACCP plan, but only if the HACCP plan explicitly references that critical limits are specified in those documents.
In addition, your HACCP plan lists water phase salt (WPS) as a critical limit at the BRINING critical control point although you are not actually measuring it on a batch by batch basis. It appears that you are actually measuring brine strength, time, and temperature, in order to achieve a WPS of 3.5% or greater in the finished product. You may wish to list as critical limits the parameters that result in a WPS of 3.5% so that you will not be required to test WPS for every batch.
4. Since you chose to include corrective actions 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, vacuum packaged, cooked smoked salmon does not indicate how you will prevent future deviations at the BRINING and SMOKING critical control points.
5. Instruments and controls used for measuring, regulating, or recording temperatures, pH, acidity, water activity, or other conditions that control or prevent the growth of undesirable microorganisms in food must be accurate and adequately maintained, to comply with 21 CFR 110.40(f). However, the instruments and controls used for measuring the internal temperatures of your seafood products in your smoker were not accurate. Specifically, on March 16, 2005, the digital temperature read out for the probe used to monitor the internal temperature of the fish in the smoker read five degrees higher than the investigator's calibrated thermometer when placed in a cup of hot water and allowed to equilibrate. In addition, the continuous temperature on the chart recorder was observed to be two degrees lower than the digital read out when the smoker was in operation on March 16, 2005.
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.
We note that your firm's HACCP plan for refrigerated, vacuum packaged, cooked, ready to eat smoked salmon lists a monitoring procedure at the "COOLING" critical control point that is not adequate to measure the critical limit. Specifically, your HACCP plan for refrigerated vacuum packaged hot smoked salmon lists monitoring the "cooling room temp" at the COOLING critical control point rather than the actual product temperature, even though your HACCP plan's critical limit reads "[p]roduct cools from 145 to 70 degrees within 2 hours and down to 40 degrees in 6 hours." In practice you are monitoring the cooling room temperature.
Please respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these deviations. You may wish to include in your response documentation such as your completed HACCP plan or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining deviations.
This letter may not list all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the Seafood HACCP regulation, and the cGMP regulation. 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: Michael J. Donovan, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021. If you have questions regarding any issue in this letter, please contact Mr. Donovan at (425) 483-4906.
Charles M. Breen