Inspections, Compliance, Enforcement, and Criminal Investigations

SIA "Piejura" 7/3/18

 

  

Black HHS-Blue FDA Logo

 

 

 
5001 Campus Drive
College Park, MD 20740
 

WARNING LETTER

JUL 3, 2018

VIA EXPRESS DELIVERY

Mihails Silovs, Manager
SIA Piejura
Nicas pagasts, Nicas novads
Avoti Liepajas Aprinkis, 3473 Latvia

Dear Mr. Silovs:

Reference# 557305

On March 23, 2018, the United States Food and Drug Administration (FDA) issued your firm a letter (untitled) explaining our significant concern with the HACCP plans for your canned sprat products. The HACCP plans were obtained during an inspection of an importer of your canned sprat products. Your firm provided a response to that letter via email on April 16, 2018. Your response included a description of corrective actions, revised HACCP Plans dated April 16, 2018, for your roasted and smoked canned sprat products, completed monitoring records, as well as additional documents pertaining to product specifications and sampling. We have evaluated the documentation and found that you have continuing serious deviations of the seafood HACCP regulation, as further explained in this letter.

In accordance with 21CFR123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with 21 CFR 123.6(g) 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 Act (21 U.S.C. § 342(a)(4)). Accordingly, your roasted sprats in tomato sauce, smoked sprats in oil, and smoked sprats in tomato sauce products are adulterated, in that they have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the 4th Edition of the Fish and Fishery Products Hazards and Controls Guidance (the Hazards Guide) through links on FDA's home page at www.fda.gov.

Your significant deviations are as follows:

1.    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 21CFR123.3(c) as a "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 ." Your revised HACCP plans dated April 16, 2018, entitled "Roasted Sprats in Tomato sauce," "Smoked sprats in tomato sauce" and "Smoked sprats in oil" list critical limits at the "(b)(4)" critical control point that are not adequate. Specifically,

a.  Regarding control of decomposition, the plans list a critical limit of "(b)(4)" that does not adequately address control of decomposition in the incoming lots. FDA recommends that firms include in their HACCP plans critical limits for sensory examination indicating that a representative sample of scombrotoxin (histamine) forming fish show decomposition (persistent and readily perceptible) in less than 2.5% of the fish in the sample, at receiving. For example, no more than (b)(4) fish in a sample of (b)(4) fish may show signs of decomposition in a lot of fish.
b.  Regarding control of histamine formation while the fish are held onboard the vessels, the plans list critical limits of "(b)(4)" that alone are not adequate. For fish held iced or refrigerated (not frozen) onboard the vessels, FDA recommends monitoring product internal temperatures at the time of off-loading from the fishing vessels as an indicator that the products have been adequately chilled or maintained in a chilled state on board the vessel. The temperature critical limit is dependent on the time between the death of the fish, or estimated time of death, and the time of making the temperature measurements. FDA recommends for fish held iced or refrigerated (not frozen) onboard the vessel
• 24 hours or more after death, internal temperature should be 40°F (4.4°C)
• 15 hours to less than 24 hours; internal temperature should be 50°F (10°C) or below
• 12 hours to less than 15 hours; internal temperature should be 60°C (15.6°C) or below
• Less than 12 hours; internal temperature below water and air temperatures
c.  Your plans do not include any critical limit to address excessive histamine formation in each lot at receipt. In addition to decomposition and internal temperature controls at receiving, FDA also recommends either obtaining harvest vessel records that document capture and holding conditions onboard the vessel; OR establishing a histamine testing strategy using a critical limit of 50 ppm for histamine as a part of your receiving process.

2.    You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6(c)(4). However, your firm's revised HACCP plans dated April 16, 2018, entitled "Roasted Sprats in Tomato sauce," "Smoked sprats in tomato sauce" and "Smoked sprats in oil" list monitoring procedures that are not adequate to control histamine formation. Specifically, your monitoring procedures at the

a. "(b)(4)" critical control points list:
i. "(b)(4)" that is not adequate for internal temperature monitoring at receipt. FDA recommends measuring the internal temperature of a representative number of the largest fish in each lot at the time of offloading, concentrating on any fish showing signs of being mishandled and monitoring the date and time of off-loading. FDA recommends measuring a minimum of 12 fish, unless there are fewer than 12 fish in a lot, in which case all the fish should be measured.
ii. "(b)(4)" that is not adequate because you do include how the number of fish that will be evaluated. FDA recommends for monitoring the decomposition step, that firms conduct an examination at least 118 fish for decomposition (persistent and readily perceptible), collected representatively throughout each lot (or the entire lot, for lots smaller than 118 fish).
b. "(b)(4)" critical control point lists that your firm will take "(b)(4). This is not adequate because it does not provide any temperature measurements between the intermittent temperature checks. For refrigerated storage, FDA recommends monitoring temperatures using a continuous monitoring and recording device with a visual check of the record and the equipment at least once per day.

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 to correct these deviations. More specifically, your response should include documentation reflecting the changes you made, such as a copy of your revised HACCP plans, five (5) consecutive days of completed monitoring records (i.e., records for the production of five (5) production date codes of the products) to demonstrate implementation of the plan, and any additional information that you wish to supply that provides assurance of your intent to fully comply now and in the future with the applicable laws and regulations. Please note that your 483 response did not include a copy of your revised HACCP plan for "Fried Sprats in Tomato Sauce," that was referenced in the Untitled Letter. Please include any revisions to this plan in your response to this letter. Submission of the information in English will assist in our review. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations.

If you do not respond or if we find your response inadequate, we may take further action. For instance, we may take further action to refuse admission of your imported fish or fishery products under Section 801(a) of the Act (21 U.S.C. § 381(a)), including placing them on detention without physical examination (DWPE). FDA's DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry. DWPE information may be conveyed in FDA's Import Alerts. For your information, an example of an Import Alert that conveys information specific to foreign firms that are not in compliance with the seafood HACCP regulation is Import Alert #16-120. You may view this alert at http://www.accessdata.fda.gov/cms_ia/ialist.html.

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 and all applicable regulations, including the seafood HACCP regulation and the Good Manufacturing Practice regulation (21 CFR 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 Food and Drug Administration, Attention: Standra Purnell, Compliance Officer, Food Adulteration Assessment Branch (HFS-607), Division of Enforcement, Office of Compliance, 5001 Campus Drive, College Park, MD 20740 U.S.A. If you have questions regarding this letter, you may contact Ms. Purnell via email at standra.purnell@fda.hhs.gov. Please reference CMS #557305 on any submissions and within the subject line of any emails to us.
 

Sincerely,
/S/
William A. Correll
Director
Office of Compliance
Center for Food Safety
    and Applied Nutrition
 

Page Last Updated: 12/04/2018
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