Inspections, Compliance, Enforcement, and Criminal Investigations
Montana Fish Company 4/10/14
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
22215 26th Ave SE, Suite 210
Bothell, WA 98021-4425
April 10, 2014
In reply refer to Warning Letter SEA 14-10
Travis I. Byerly
Montana Fish Company
1401 Gold Avenue, Suite 2B
Bozeman, Montana 59715-2403
Dear Mr. Byerly:
We inspected your seafood processing facility, located at 1401 Gold Avenue, Suite 2B, Bozeman, Montana, on March 4, 5, 7, and 11, 2014. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations (CFR), Part 123. 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 refrigerated, canned crab products and your scombroid species and related fish are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby theymay 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.
We received your letter dated March 21, 2014, written in response to the Form FDA 483, Inspectional Observations, issued to you on March 11, 2014. Your response is inadequate in that you did not provide any documentation to verify corrections.
Your significant violations were as follows:
1. You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you process to determine whether there are food safety hazards that are reasonably likely to occur and you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (b). However, your firm has not conducted a hazard analysis and does not have a HACCP plan for refrigerated, canned, Super Lump Crabmeat or for refrigerated, canned, Claw Crabmeat to control the food safety hazard of Clostridium botulinum. Both of these products are labeled as “Keep Refrigerated.”
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 123.3(c) as "the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point (CCP) to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard." However, your firm’s HACCP plan for “Scombroid species and related fishes” lists a critical limit at the “Receive product” CCP of “Inspect container for adequate quantity and temperature of chemical ice packs at time of delivery,” which does not ensure the control of the hazard of scombrotoxin formation by ensuring internal temperature of the product remains at 40 degrees F or below throughout transit.
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 scombrotoxin when your process for scombroid species deviated from your critical limit at the “Unfinished & Finished product cooler storage” CCP. Specifically, your continuous temperature recording device was measuring a consistent temperature of 45 degrees F from June 3, 2013 to June 9, 2013. Your Receiving Log indicates you received Ahi #1 tuna on June 6, 2013, and stored them in your walk-in refrigerator.
4. You must implement the monitoring procedures and frequency that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b) and 21 CFR 123.6(c)(4). However, your firm did not follow the monitoring procedure of “Measure internal temp of fish every shipment: temp @ (b)(4)” at the “Receive product” CCP to control scombrotoxin listed in your HACCP plan for “Scombroid species and related fishes.” Specifically, you are not recording a temperature of any fish at receiving.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your products 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.
Additionally, Section 743 of the Act (21 U.S.C. § 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees [21 U.S.C. § 379j-31(a)(2)(B)]. For a foreign facility, FDA will assess and collect fees for re-inspection-related costs from the U.S. Agent for the foreign facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Please send your reply to the Food and Drug Administration, Attention: Patricia A. Pinkerton, Compliance Officer at 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021. If you have any questions regarding any issues in this letter, please contact Patricia Pinkerton at 425-302-0428.
Ann M. Adams, PhD
Acting District Director
cc: Montana DPHHS Food and Consumer Safety
P.O. Box 202951
Helena, Montana 59620
Seafood Inspection Program
USDC, NOAA, NMFS
1315 East-West Highway
Silver Spring, Maryland 20910
Division of Seafood Safety (HFS-315)
FDA, Office of Food Safety
5100 Pain Branch Parkway
College Park, Maryland 20740