Inspections, Compliance, Enforcement, and Criminal Investigations
Trilogy Crab Co. Inc. 10/16/09
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
22201 23rd Drive SE
Bothell, WA 98021-4421
October 16, 2009
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 10-04
Johanna E. Porter, Owner
The Trilogy Crab Co., Inc.
408 East Horton Road
Bellingham, Washington 98228
Dear Ms. Porter:
We inspected your seafood processing facility, located at 408 East Horton Road, Bellingham, Washington, on June 3, 4, 6, and 18,2009. 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 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 "Cook" and "Storage" critical control points to control pathogen growth and toxin formation as listed in your HACCP plan for "Dungeness Crab". Specifically,
a. Your firm was not monitoring and recording the "Process Temperature" at the "Cook"
critical control point as listed in your plan. During our inspection, we found that temperatures were not taken or recorded. Further, your record "Trilogy Crab Co.Cook record" documents only start times and end times for the cook. It does not document the temperature of the cook, nor does it document that the water was at a rolling boil throughout the required time, which would also be an acceptable method of monitoring at this critical control point.
b. Your firm was not monitoring and recording the "Cooler storage and/or ice storage at or below (b)(4) degrees Fahrenheit" at the "Storage" critical control point as listed in your plan. No temperatures are monitored or recorded for product storage. During our inspection, we found typically only a (b)(4) ice check is performed and recorded.
FDA recommends the use of a digital temperature logger to monitor refrigerated storage units.
2. 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 "Dungeness Crab" does not list a minimum or maximum value at the "Cool" critical control point to control pathogen growth and toxin formation. Your plan states only "(b)(4) until cool" which does not include a minimum or maximum value. The monitoring step at this critical control point states that monitoring will be accomplished by monitoring the "cooked crab internal temperature." No internal temperatures of crab are monitored or recorded by your firm.
3. You must take an appropriate corrective action when a deviation from a critical limit occurs, to comply with 21 CFR 123.7(a). However, your firm did not take a corrective action to control the hazard of pathogen survival when your process for ready-to-eat crabmeat deviated from your critical limit at the "Cook" critical control point. Your HACCP plan for "Dungeness Crab" requires a (b)(4) minute cook. Your "Trilogy Crab Co. Cook record" documents that on June 5, 2009, and June 6, 2009, crab was cooked for only (b)(4) minutes on both days. There is no documentation that this deviation was identified or that a corrective action was taken.
4. 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 "Dungeness Crab" at the "Cook" critical control point to control pathogen survival through cooking, and at the "Cool" and "Storage" critical control points to control pathogen growth and toxin formation 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.
5. You must retain records at the processing facility for at least one year after the date they were prepared, in the case of refrigerated products, to comply with 21 CFR 123.9(b)(1). However, your firm's sanitation monitoring records for time periods when refrigerated
ready-to-eat crabmeat products were produced, between June 5 and August 7, 2008, were not retained.
6. 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 safety of water, including water used to manufacture ice, which comes in contact with food or food contact surfaces; prevention of cross-contamination from insanitary objects to food, food packaging material, and other food contact surfaces; 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; and exclusion of pests with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110, as evidenced by:
a. at least two hoses were connected to water sources without back-flow prevention devices;
b. plastic wrap covered Styrofoam ice chests which are used for live Dungeness crab shipment were stored on the outside of the firm. The chests were stored wrapped in a plastic wrap. The plastic wrap was tom away which exposed the external portions of the Styrofoam ice chests. There was apparent bird excreta observed on the wrapped portions of these ice chests. These stacks of wrapped chest are then brought into the processing areas of the firm, where employees handle the chests, the plastic wrap, processing equipment, and live crabs.
c. the crab rake, used to remove crab from the crab cooking pot, was observed to be stored against an unsanitized wall in the cooking room;
d. one employee was observed to handle insanitary objects such as the tote lid and wash handle, and then handle cooked picked crabmeat without first sanitizing gloved hands;
e. one exterior door at the East side of the building was left open to the interior of the building for hours throughout the inspection providing an access point for pests;
f. one dog was observed entering the interior of the kitchen area where crab picking and packing is conducted; and
g. during the inspection, weeds were growing and unused equipment was stored along the exterior area of the building providing a harborage area for pests.
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.
For your information, we noted that your Processing Narrative in your HACCP Plan states that you perform a verification step to assure that live crab you receive has been caught in a state mandated area. We recommend that you ensure your hazard analysis has considered whether environmental chemical contaminants and pesticides is a significant hazard. For additional information concerning the hazard of chemicals, please refer to Chapter 9 of the Fish and Fisheries Products Hazards and Controls Guidance: 3rd Edition.
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 (2] 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: Lisa M. Althar, Compliance Officer, 22201 23I'd Drive SE, Bothell, WA 98021-4421. If you have any questions regarding this letter, please contact Lisa Althar at (425) 483-4940.
Charles M. Breen
cc: WSDA with disclosure statement