George A. Osborne
- Eagle Smoked Salmon, Inc.
452 Vicksburg Lane
Gypsum, CO 81637
- Issuing Office:
- Denver District Office
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Denver District Office
P.O. Box 25087
Denver, CO 80225
August 23, 2017
Via UPS Overnight
Ref: # HAF4W(DEN)-17-15-WL
George A. Osborne, Owner
Eagle Smoked Salmon, Inc.
452 Vicksburg Lane
Gypsum, CO 81637
Dear Mr. Osborne:
On July 13 and 17, 2017, the U.S. Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility located at 452 Vicksburg Lane, Gypsum, Colorado. The inspection identified 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 vacuum packed cold smoked salmon, hot smoked salmon (not vacuum packed), and Smoked Salmon Spread 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 regulations, and the Fish and Fishery Products Hazards and Controls Guidance
through links on FDA’s website at www.fda.gov
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 does not have a HACCP plan for your Smoked Salmon Spread to control the food safety hazards of pathogen growth and undeclared major food allergens.
We acknowledge receipt of your letter dated July 20, 2017, which included a proposed HACCP plan for the “Smoked Salmon Spread”. However, the plan does not include steps to control pathogenic bacteria growth in the raw materials and finished products. Additionally, the plan does not include control measures to ensure the allergens, egg, milk, and fish are properly declared on all finished product labels.
2) 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 (CCP), 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 HACCP plan for “Cold Smoked Salmon Vacuum Packed” does not list critical control points for the food safety hazards of pathogen growth at receiving of raw salmon and metal inclusion for finished products.
We acknowledge receipt of your letter dated July 20, 2017, which included a proposed HACCP plan for the “Cold Smoked Salmon Vacuum Packed.” However, the critical limit you proposed of “Fish Temp not to exceed (b)(4) degrees F and boxes sealed and visually check” is not adequate to limit the growth of pathogenic bacteria growth in the raw salmon. Additionally, the plan’s monitoring section states that the “Temp and Quality” are checked for “Every Shipment.” Even if your critical limit for this critical control point was correct, these monitoring procedures are not appropriate to ensure salmon is received at a temperature which limits the pathogenic bacteria growth. Further, your proposed HACCP plan includes a CCP for packaging which details a visual check of the mechanical blade used for cutting the cold smoked salmon. As we did not receive documentation that details implementation of this step, we will evaluate this response during our next inspection.
3) You must have a HACCP plan that lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6(c)(4). However, your HACCP plan for “Cold Smoked Salmon Vacuum Packed” lists a monitoring procedure and frequency at the storage CCP that is not adequate to control the growth of Clostridium botulinum.
We acknowledge receipt of your letter dated July 20, 2017, which included a proposed HACCP plan for “Cold Smoked Salmon Vacuum Packed.” Finished products are stored in the walk-in cooler (b)(4) per day. The monitoring procedures listed in the proposed plan are not adequate to ensure the critical limit is consistently met to control growth of Clostridium botulinum. Additionally, you explained to the Investigator that an alarm sounds when the temperature reaches (b)(4)oF. Even if this was an appropriate temperature for your vacuum packed cold smoked salmon, your firm does not ensure the device is operational.
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). During our inspection we found the following:
a) Your firm did not follow the monitoring procedure of “Thermometer Logger” and frequency of “Throughout the Process” at the smoking critical control point. This CCP is intended to control “pathogen growth in finished product” that you list in your “Salmon Not Vacuum Packed” HACCP plan used to process hot smoked salmon. Specifically, your processing records do not include a reference to continuous temperature monitoring taken by the “Thermometer Logger.”
b) At your curing CCP, your firm did not follow the monitoring procedure defined as “Time in Cure,” “Salt content of cure,” and “Weight of fish and salt,” each with frequencies of “Each Batch.” This CCP is intended to control “C. bot, Staph, and Listeria Production (sic) in finished product” listed in your “Cold Smoked Vacuum Packed” HACCP plan. Specifically, your firm does not create records detailing the monitoring of the critical limits listed in the curing critical control point.
c) Your firm did not follow the monitoring procedure and frequency of “Temp Logger” and “Continuous” at the storage critical control point to control “Pathogen Growth in Finished Product” listed in your “Salmon Not Vacuum Packed” HACCP plan. Specifically, your firm does not have continuous temperature monitoring data to demonstrate the compliance with your critical limit from April 30, 2017 through the inspection ending on July 17, 2017. Your firm processed approximately (b)(4) batches of vacuum packed cold smoked and hot smoked salmon during the timeframe above. Further, no corrective actions were taken to ensure the safety of the product during this timeframe.
We acknowledge receipt of your letter dated July 20, 2017. However, you did not provide any records to demonstrate that the issues listed in a-c of this section have been corrected.
5) 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, we found the following:
a) Your corrective action plan for “Salmon Not Vacuum Packed” at the smoking and storage critical control points intended to control pathogenic bacteria growth is not appropriate. Both steps indicate that you will “Hold Product and Evaluate” when a deviation occurs. This action does not ensure the cause of the deviation is appropriately corrected.
b) Your corrective action plan for “Cold Smoked Vacuum Packed” salmon at the smoking critical control point intended to control Clostridium botulinum is not appropriate. The plan states that your firm will “Hold Product and Evaluate;” this does not ensure the cause of the deviation is appropriately corrected. Further, the corrective action plan listed at the storage critical control point to control Clostridium botulinum is not appropriate. The plan states your firm will “Readjust cooler;” this does not ensure no product enters commerce that is injurious to health or is otherwise adulterated as a result of the deviation.
6) Your HACCP plans must include on-going verification activities, including calibration of process monitoring instruments, to comply with 21 CFR 123.8(a)(2). Your “Salmon Not Vacuum Packed” and “Cold Smoked Salmon Vacuum Packed” plans do not include verifying the accuracy of and/or calibration of your thermometers and temperature monitoring instruments used to monitor the critical control points at Receiving and Storage. Additionally, you were unable to provide the Investigator with calibrations records during the inspection.
We acknowledge receipt of your letter dated July 20, 2017. However, you did not provide any records which demonstrate this observation has been corrected.
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations. 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. You should take prompt action to correct or implement corrections to the violations cited in this letter. Failure to do so may result in regulatory enforcement action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure and/or injunction.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking or have taken to correct these deviations, including an explanation of how your firm plans to prevent these violations, or similar violations from occurring again. More specifically, your response should include documentation of the corrections and/or corrective actions (which must address systemic problems) your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen (15) business days, state the reason for the delay and the time within which these activities will be completed.
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 one or more inspections 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 domestic facility, FDA will assess and collect fees for re-inspection related costs from the responsible party for the domestic 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 from the responsible party for the domestic facility.
Your reply should be addressed to the U.S. Food and Drug Administration; Attn: Jacob W. Reynolds, Compliance Officer, P.O. Box 25087, Denver, Colorado, 80225-0087. You may reach Mr. Reynolds at (480) 829-7396 x2011 if you have any questions about this matter.
LaTonya M. Mitchell
Program Division Director
Office of Human and Animal Foods-
Division IV West
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