Inspections, Compliance, Enforcement, and Criminal Investigations
Newman's Fish Markets, Inc. 12/7/10
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
December 7, 2010
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 11-04
Mr. John M. Cleary, Secretary/Co-owner
Newman’s Fish Markets, Inc.
2601 N. Newark Street, Suite E
Portland, Oregon 97217-6925
Dear Mr. Cleary:
We inspected your seafood processing facility, located at 2601 N. Newark Street, Suite E, Portland, Oregon, on August 19, 20, and 23, 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, 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 smoked, vacuum-packaged, refrigerated salmon; hot smoked vacuum-packaged, refrigerated sturgeon; and hot smoked, vacuum-packaged, refrigerated escolar, tuna, and black cod 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. We received a response from you by facsimile on September 7, 2010, concerning our investigator’s observations noted on the Form FDA 483, Inspectional Observations, issued to you at the conclusion of the inspection. We address this response below, as it relates to the noted violations.
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 produce to determine whether there are food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (b). However, your firm does not have a HACCP plan for hot smoked, vacuum-packaged refrigerated sturgeon to control the food safety hazard of Clostridium botulinum and environmental chemical contaminants. Our investigator confirmed with you that you smoked a batch of fish on July 29, 2010, that included sturgeon.
You advised our investigator that your firm would freeze all of your vacuum packaged products to eliminate the hazard of Clostridium botulinum. Your response received on September 7, 2010, stated that each package will have a sticker informing customers to keep product in a cooler at 38ºF or less. You then state you will have a sticker informing customers to “keep frozen until used; thaw under refrigeration immediately before use.” It is unclear by these statements what your intended use is for this product. FDA considers Clostridium botulinum a reasonably likely hazard for refrigerated vacuum packaged fishery products and frozen vacuum packaged fishery products that are not clearly labeled to be kept frozen for safety and thawed under refrigeration immediately prior to use.
2. 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 Clostridium botulinum when the process during a batch of hot smoked, vacuum-packed, refrigerated salmon deviated from your critical limit at the Smoking/Cooking critical control point (CCP). Our investigator found that your data logger graph dated July 28, 2010 (you discussed with our investigator on August 23, 2010, that this record should have been dated July 29, 2010), indicated a piece of fish that represented the batch only reached an internal temperature of (b)(4) ºF for (b)(4) minutes, |(b)(4) seconds. Your HACCP plan for hot smoked salmon states that the critical limit at the Smoking/Smoking critical control point (CCP) must be (b)(4)ºF for (b)(4) minutes.
Further, your firm did not take corrective actions to control the hazard of histamines when the process for hot smoked, vacuum-packaged, refrigerated escolar and tuna deviated from your critical limit at the Refrigerated Storage CCP. On July 15, 2010, in cooler #(b)(4), in which you store finished product, the critical limit of (b)(4)ºF was exceeded from 6:30pm-8:00pm. The highest temperature of the cooler during this time was (b)(4)ºF.
Your response received on September 7, 2010, did not specifically address the cause of the deviations, and how you will prevent them from recurring in the future.
3. You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce 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 food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (c)(1). A food safety hazard is defined in 21 CFR 123.3(f) as “any biological, chemical, or physical property that may cause the food to be unsafe for human consumption.”
• However, your firm’s HACCP plan for hot smoked, black cod does not list the food safety hazard of Clostridium botulinum at the “Refrigerated Storage” CCP. Your response received on September 7, 2010, included a revised HACCP plan for your hot smoked, vacuum-packaged refrigerated escolar and tuna. You did not include black cod in your revised HACCP plan.
• However, your firm’s revised HACCP plan for escolar and tuna does not identify the hazard of histamine formation. You have eliminated “Brining” as a CCP. Although the formation of Clostridium botulinum may not be a significant hazard for this product if it is labeled to be held frozen and thawed under refrigeration immediately before use, histamine formation is considered a food safety hazard that is reasonably likely to occur at the “Brining” CCP.
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 (c)(4). However, your firm did not follow the monitoring procedures of “minimum salt content” and “Minimum (b)(4) ratio of brine to fish” at the Brining CCP listed in your HACCP plans for hot smoked, vacuum-packaged, refrigerated escolar, tuna, and black cod; and hot smoked, vacuum-packaged, refrigerated salmon.
5. 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 hot smoked, vacuum-packed, frozen escolar and tuna does not list the critical control point of thawing for controlling the food safety hazard of histamine formation. According to your hazard analysis you are controlling this hazard through refrigeration and icing. Those controls should be listed in your HACCP plan.
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 reply to the Food and Drug Administration, Attention: Lisa M. Elrand, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington, 98021-4421. If you have questions regarding any issues in this letter, please contact Ms. Elrand at 425-483-4913.
Charles M. Breen
Copy of FDA 483
cc: ODA with disclosure statement